The following data is part of a premarket notification filed by Starkey Laboratories, Inc. with the FDA for Starkey Laboratories Otoscope.
| Device ID | K922752 |
| 510k Number | K922752 |
| Device Name: | STARKEY LABORATORIES OTOSCOPE |
| Classification | Otoscope |
| Applicant | STARKEY LABORATORIES, INC. 6700 WASHINGTON AVE. SOUTH Eden Prairie, MN 55344 |
| Contact | Jerrold Lang |
| Correspondent | Jerrold Lang STARKEY LABORATORIES, INC. 6700 WASHINGTON AVE. SOUTH Eden Prairie, MN 55344 |
| Product Code | ERA |
| CFR Regulation Number | 874.4770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-08 |
| Decision Date | 1992-09-04 |