The following data is part of a premarket notification filed by Starkey Laboratories, Inc. with the FDA for Hearing Ambassador-hear Pen Screening Audiometer.
| Device ID | K902068 |
| 510k Number | K902068 |
| Device Name: | HEARING AMBASSADOR-HEAR PEN SCREENING AUDIOMETER |
| Classification | Audiometer |
| 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 | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-07 |
| Decision Date | 1990-08-06 |