The following data is part of a premarket notification filed by Grason-stadler, Inc. with the FDA for Gsi Sa60 Dpoae System.
| Device ID | K970324 |
| 510k Number | K970324 |
| Device Name: | GSI SA60 DPOAE SYSTEM |
| Classification | Calibrator, Hearing Aid / Earphone And Analysis Systems |
| Applicant | GRASON-STADLER, INC. 1 WESTCHESTER DR. Milford, NH 03055 -3056 |
| Contact | Norman L Schultz |
| Correspondent | Norman L Schultz GRASON-STADLER, INC. 1 WESTCHESTER DR. Milford, NH 03055 -3056 |
| Product Code | ETW |
| CFR Regulation Number | 874.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-27 |
| Decision Date | 1997-06-06 |
| Summary: | summary |