The following data is part of a premarket notification filed by Viasys Healthcare, Inc. with the FDA for Audiometer, Otoacoustic Emission, Auditory Branstem Response Access.
| Device ID | K031713 |
| 510k Number | K031713 |
| Device Name: | AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACCESS |
| Classification | Audiometer |
| Applicant | VIASYS HEALTHCARE, INC. 800 LEVANGER LN. Stoughton, WI 53589 |
| Contact | Gary Syring |
| Correspondent | Gary Syring VIASYS HEALTHCARE, INC. 800 LEVANGER LN. Stoughton, WI 53589 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-02 |
| Decision Date | 2003-08-12 |
| Summary: | summary |