The following data is part of a premarket notification filed by Grason-stadler, Inc. with the FDA for Gsi 2000 Middle Ear Analyzer.
| Device ID | K000097 |
| 510k Number | K000097 |
| Device Name: | GSI 2000 MIDDLE EAR ANALYZER |
| Classification | Tester, Auditory Impedance |
| 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 | ETY |
| CFR Regulation Number | 874.1090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-13 |
| Decision Date | 2000-04-12 |