The following data is part of a premarket notification filed by Maico Hearing Instruments, Inc. with the FDA for Audiometer, Portable, Air Conduction.
| Device ID | K780382 |
| 510k Number | K780382 |
| Device Name: | AUDIOMETER, PORTABLE, AIR CONDUCTION |
| Classification | Audiometer |
| Applicant | MAICO HEARING INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-03-10 |
| Decision Date | 1978-03-14 |