510(k) K934432
K934432 is an FDA 510(k) premarket notification submitted by Smith & Nephew Richards, Inc. for the device "OTOVIEW ENDOSCOPY SYSTEM". The FDA issued a decision of Substantially Equivalent on Apr 25, 1994. The device falls under product code EWA (Set, Audiometer Calibration), a Class I device regulated under 21 CFR 874.1080. Smith & Nephew Richards, Inc. has 86 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 25, 1994
- Date Received
- Sep 13, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Set, Audiometer Calibration
- Device Class
- Class I
- Regulation Number
- 874.1080
- Review Panel
- EN
- Submission Type
- 510(k) Exempt