The following data is part of a premarket notification filed by Amplivox, Ltd. with the FDA for Otowave 202 Portable Tympanometer.
| Device ID | K150163 |
| 510k Number | K150163 |
| Device Name: | Otowave 202 Portable Tympanometer |
| Classification | Tympanometer |
| Applicant | AMPLIVOX, LTD. 6 Oasis Park Eynsham, GB Ox29 4tp |
| Contact | Chris Roerig |
| Correspondent | Daniel Kamm Kamm & Associates 8870 RAVELLO CT. Naples, FL 34114 |
| Product Code | NAS |
| CFR Regulation Number | 874.1090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-26 |
| Decision Date | 2015-04-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060488901003 | K150163 | 000 |