The following data is part of a premarket notification filed by Natus Medical Incorporated with the FDA for A Baer With Abaer I/o Function.
| Device ID | K112247 |
| 510k Number | K112247 |
| Device Name: | A BAER WITH ABAER I/O FUNCTION |
| Classification | Audiometer |
| Applicant | NATUS MEDICAL INCORPORATED 388 MARKET STREET SUITE 1460 San Francisco, CA 94111 |
| Contact | Charles L Morin |
| Correspondent | Charles L Morin NATUS MEDICAL INCORPORATED 388 MARKET STREET SUITE 1460 San Francisco, CA 94111 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-04 |
| Decision Date | 2012-04-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830001090 | K112247 | 000 |