The following data is part of a premarket notification filed by Grason-stadler, Inc. with the FDA for Gsi 61 Clinical Audiometer.
| Device ID | K953684 |
| 510k Number | K953684 |
| Device Name: | GSI 61 CLINICAL AUDIOMETER |
| Classification | Audiometer |
| Applicant | GRASON-STADLER, INC. 1 WESTCHESTER DR. Milford, NH 03055 -3056 |
| Contact | Janice E Painter |
| Correspondent | Janice E Painter GRASON-STADLER, INC. 1 WESTCHESTER DR. Milford, NH 03055 -3056 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-03 |
| Decision Date | 1995-10-27 |