The following data is part of a premarket notification filed by Jedmed Instrument Co. with the FDA for Bera Sh 221 Brian Stem Audiometer.
| Device ID | K830173 |
| 510k Number | K830173 |
| Device Name: | BERA SH 221 BRIAN STEM AUDIOMETER |
| Classification | Antigens, Ha, Echovirus 1-34 |
| Applicant | JEDMED INSTRUMENT CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GNJ |
| CFR Regulation Number | 866.3205 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-01-18 |
| Decision Date | 1983-05-25 |