K974237 is an FDA 510(k) clearance for the GSI 70 AUDIOPATH SCREENER. This device is classified as a Audiometer (Class II - Special Controls, product code EWO).
Submitted by Grason-Stadler, Inc. (Milford, US). The FDA issued a Cleared decision on February 10, 1998, 90 days after receiving the submission on November 12, 1997.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1050.
| 510(k) Number | K974237 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 12, 1997 |
| Decision Date | February 10, 1998 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | EWO — Audiometer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.1050 |