The following data is part of a premarket notification filed by Amplivox, Ltd. with the FDA for Amplivox Otowave 102 Hand Held Portable Tympanometer.
| Device ID | K081841 |
| 510k Number | K081841 |
| Device Name: | AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER |
| Classification | Tester, Auditory Impedance |
| Applicant | AMPLIVOX, LTD. P.O. BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Jay Y Kogoma INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | ETY |
| CFR Regulation Number | 874.1090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-06-30 |
| Decision Date | 2008-07-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060488901010 | K081841 | 000 |