The following data is part of a premarket notification filed by Starkey Laboratories, Inc. with the FDA for Deskrem-1000.
| Device ID | K943459 |
| 510k Number | K943459 |
| Device Name: | DESKREM-1000 |
| Classification | Calibrator, Hearing Aid / Earphone And Analysis Systems |
| Applicant | STARKEY LABORATORIES, INC. 6600 & 6700 WASHINGTON AVE SO Eden Prairie, MN 55344 |
| Contact | Rick Stromberg |
| Correspondent | Rick Stromberg STARKEY LABORATORIES, INC. 6600 & 6700 WASHINGTON AVE SO Eden Prairie, MN 55344 |
| Product Code | ETW |
| CFR Regulation Number | 874.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-18 |
| Decision Date | 1994-10-21 |