The following data is part of a premarket notification filed by Starkey Laboratories, Inc. with the FDA for Starkey Model Hal-1.
| Device ID | K821908 |
| 510k Number | K821908 |
| Device Name: | STARKEY MODEL HAL-1 |
| Classification | Calibrator, Hearing Aid / Earphone And Analysis Systems |
| Applicant | STARKEY LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ETW |
| CFR Regulation Number | 874.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-28 |
| Decision Date | 1982-08-03 |