AccessGUDID - DEVICE: SmartAudiometer Software (00817020020877)

GUDID

Device Identifier (DI) Information

Brand Name: SmartAudiometer Software
Version or Model: M817000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: INTELLIGENT HEARING SYSTEMS CORP.

Primary DI Number: 00817020020877
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 154870455 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
37503	Tone audiometer	An electroacoustic device intended for use in a clinical setting to generate tones in the audible range to measure the hearing threshold of a patient by establishing the level at which the patient first becomes aware of the sounds. The device controls tone intensity and frequency either by a computer or manually, and displays/records the patient's responses, typically in the form of an audiogram. It may include a bone vibrator for direct inner-ear stimulation.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EWO	Audiometer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K900096	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 11904e93-2e2d-4370-9879-3f64227a4c55
Public Version Date: August 03, 2023
Public Version Number: 4
DI Record Publish Date: September 24, 2016