The following data is part of a premarket notification filed by Rion Acoustic Instruments, Inc. with the FDA for Rion Diagnostic Audiometer.
| Device ID | K802207 |
| 510k Number | K802207 |
| Device Name: | RION DIAGNOSTIC AUDIOMETER |
| Classification | Audiometer |
| Applicant | RION ACOUSTIC INSTRUMENTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-09-11 |
| Decision Date | 1980-09-26 |