The following data is part of a premarket notification filed by Rion Acoustic Instruments, Inc. with the FDA for Rion Audiometer Aa-68.
| Device ID | K812952 |
| 510k Number | K812952 |
| Device Name: | RION AUDIOMETER AA-68 |
| Classification | Plate, Cranioplasty, Preformed, Alterable |
| Applicant | RION ACOUSTIC INSTRUMENTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GWO |
| CFR Regulation Number | 882.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-10-21 |
| Decision Date | 1981-11-06 |