The following data is part of a premarket notification filed by Smith & Nephew Richards, Inc. with the FDA for Otoview Endoscopy System.
| Device ID | K934432 |
| 510k Number | K934432 |
| Device Name: | OTOVIEW ENDOSCOPY SYSTEM |
| Classification | Set, Audiometer Calibration |
| Applicant | SMITH & NEPHEW RICHARDS, INC. 2929 APPLING RD. Bartlett, TN 38133 |
| Contact | Ronald K Smith |
| Correspondent | Ronald K Smith SMITH & NEPHEW RICHARDS, INC. 2929 APPLING RD. Bartlett, TN 38133 |
| Product Code | EWA |
| CFR Regulation Number | 874.1080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-13 |
| Decision Date | 1994-04-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925027411 | K934432 | 000 |
| 00821925019195 | K934432 | 000 |
| 00821925019201 | K934432 | 000 |
| 00821925019379 | K934432 | 000 |
| 00821925019386 | K934432 | 000 |
| 00821925027183 | K934432 | 000 |
| 00821925027190 | K934432 | 000 |
| 00821925027206 | K934432 | 000 |
| 00821925027213 | K934432 | 000 |
| 00821925019188 | K934432 | 000 |