The following data is part of a premarket notification filed by American Electromedics Corp. with the FDA for K 15 Audiometer.
| Device ID | K972221 |
| 510k Number | K972221 |
| Device Name: | K 15 AUDIOMETER |
| Classification | Audiometer |
| Applicant | AMERICAN ELECTROMEDICS CORP. 13 COLUMBUS DR. SUITE 18 Amherst, NH 03031 |
| Contact | Michael T Pieniazek |
| Correspondent | Michael T Pieniazek AMERICAN ELECTROMEDICS CORP. 13 COLUMBUS DR. SUITE 18 Amherst, NH 03031 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-13 |
| Decision Date | 1997-09-08 |