The following data is part of a premarket notification filed by Grason-stadler Inc. with the FDA for Gsi Novus.
| Device ID | K172403 |
| 510k Number | K172403 |
| Device Name: | GSI Novus |
| Classification | Audiometer |
| Applicant | Grason-Stadler Inc. 10395 West 70th Street Eden Prairie, MN 55344 |
| Contact | Amy Yanta |
| Correspondent | Amy Yanta Grason-Stadler Inc. 10395 West 70th Street Eden Prairie, MN 55344 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-09 |
| Decision Date | 2017-10-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810046700129 | K172403 | 000 |