The following data is part of a premarket notification filed by Everest Biomedical Instruments Co. with the FDA for Audioscreener Oae+abr.
| Device ID | K024205 |
| 510k Number | K024205 |
| Device Name: | AUDIOSCREENER OAE+ABR |
| Classification | Audiometer |
| Applicant | EVEREST BIOMEDICAL INSTRUMENTS CO. 16690 SWINGLEY RIDGE RD. SUITE 140 Chesterfield, MO 63017 |
| Contact | Randall Krohn |
| Correspondent | Randall Krohn EVEREST BIOMEDICAL INSTRUMENTS CO. 16690 SWINGLEY RIDGE RD. SUITE 140 Chesterfield, MO 63017 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-20 |
| Decision Date | 2003-03-07 |
| Summary: | summary |