510(k) K822335
K822335 is an FDA 510(k) premarket notification submitted by Axonics, Inc. for the device "AUDIT". The FDA issued a decision of Substantially Equivalent on February 7, 1983. The device falls under product code EWO (Audiometer), a Class II device regulated under 21 CFR 874.1050. Axonics, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 7, 1983
- Date Received
- August 4, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Audiometer
- Device Class
- Class II
- Regulation Number
- 874.1050
- Review Panel
- EN
- Submission Type