The following data is part of a premarket notification filed by Tympany, Inc. with the FDA for Otogram, Ca3350.
| Device ID | K070118 |
| 510k Number | K070118 |
| Device Name: | OTOGRAM, CA3350 |
| Classification | Audiometer |
| Applicant | TYMPANY, INC. 2795 EAST COTTONWOOD PKWY. SUITE 660 Salt Lake City, UT 84121 |
| Contact | Lex J Pearce |
| Correspondent | Lex J Pearce TYMPANY, INC. 2795 EAST COTTONWOOD PKWY. SUITE 660 Salt Lake City, UT 84121 |
| Product Code | EWO |
| Subsequent Product Code | ETY |
| Subsequent Product Code | NAS |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-12 |
| Decision Date | 2007-03-07 |
| Summary: | summary |