DEVICE: Self Vision Tester (08800074500213)
Device Identifier (DI) Information
Self Vision Tester
VAA-2000PCE
In Commercial Distribution
VAA-2000PCE
VIEW-M TECHNOLOGY CO., LTD.
VAA-2000PCE
In Commercial Distribution
VAA-2000PCE
VIEW-M TECHNOLOGY CO., LTD.
When users put their forehead to the forehead sensor, VAA-2000PCE starts the examination automatically. To see the indications (pictures, numbers, Korean Alphabet, Landolt rings and etc.) through the tester’s eyepiece, users keep eyes on the indication in the middle of background and the indications on every sides. Then move the lever to the same indication to the indication in the middle. If users cannot distinguish the indications, push on of the red buttons on the left and right sides to forgive. Then it skips the phase and change to next indication. When the exam finished, the device analyzes user’s choices and give the result data of the exam. Users can check their eyesight data by printing it from device. In addition, the device prevents user’s mistake by voice guidance
To start the color-blindness test, touch the 10.1-inch LCD touch-screen at the top of the device. The indications on the center of the screen are displayed on the LCD touch screen. Touch the displayed indication by one-step multiple-choice color vision test, and then the same type of color vision test will be performed in several steps. Users touch the LCD screen to proceed with the test, the test will be completed. After the test is completed, you can print out the results of the color test on the print paper by touching the print button on the touch screen.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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16800 | Vision testing/training chart |
An ophthalmic chart or card printed with various symbols (e.g., letters, pictures or dots) intended to be used for testing visual acuity (e.g., Snellen chart) or testing and/or training accommodation and/or convergence or other amenable ophthalmic functions. The chart/card may be held in front of the patient or placed on a table or wall and may have specific user instructions depending on specific use. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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HOX | Chart, Visual Acuity |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal |
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity |
Handling Environment Temperature: between 10 and 40 Degrees Celsius |
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal |
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity |
Storage Environment Temperature: between -10 and 55 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
7f4f6ede-f74b-410f-b313-516fe4c32f38
April 02, 2024
1
March 25, 2024
April 02, 2024
1
March 25, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined