Audio Expert Audiometer
FDA 510(k) K942716 · Beltone Electronics Corp.
510(k) numberK942716
Submission
- Device name
- Audio Expert Audiometer
- Applicant
- Beltone Electronics Corp.
Chicago, IL, US - Received
- June 9, 1994
- Decision date
- September 2, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EWO – Audiometer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.1050
- Specialty
- Ear, Nose, Throat
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Questions and answers
When was Audio Expert Audiometer cleared by the FDA?
Audio Expert Audiometer (K942716) received a 510(k) decision of Substantially Equivalent on September 2, 1994, 85 days after the submission was received.
What is the product code of K942716?
The FDA product code is EWO – Audiometer, a Class II (moderate risk) device regulated under 21 CFR 874.1050.