The following data is part of a premarket notification filed by Kells Medical, Inc. with the FDA for Impedance Meter On-1.
| Device ID | K823227 |
| 510k Number | K823227 |
| Device Name: | IMPEDANCE METER ON-1 |
| Classification | Tester, Auditory Impedance |
| Applicant | KELLS MEDICAL, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | ETY |
| CFR Regulation Number | 874.1090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-10-29 |
| Decision Date | 1982-11-22 |