DEVICE: SleepView Starter Kit (B1437000011112)

Device Identifier (DI) Information

SleepView Starter Kit
International
In Commercial Distribution
700-0011-11
Cleveland Medical Devices Inc.
B1437000011112
HIBCC

1
557510625 *Terms of Use
SleepView International Starter Kit
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
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Yes
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Electroencephalograph A line-powered device used to record the variations of the electrical potential caused by the electrical activity of the brain, usually detected at the patient's scalp. Leads affixed to the scalp and ear lobes transmit the electric signals to the recorder, which in turn reproduces their characteristics in an electroencephalogram (EEG). They are used to study a variety of neurological conditions, evaluate psychiatric disorders and assist in localizing tumours or lesions on or near the surface of the brain.
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FDA Product Code

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Product Code Product Code Name
GWQ Full-Montage Standard Electroencephalograph
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K042039 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

7347c9d7-7156-44a4-a611-bebaa230fcd7
July 06, 2018
3
September 23, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
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No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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