510(k) K171265
- Device
- Otowave 302 Portable Tympanometer
- Applicant
- Amplivox Ltd
- 510(k) number
- K171265
- Product code
- NAS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-07-28
- Date received
- 2017-05-01
- Regulation
- 874.1090
- Classification name
- Tympanometer
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Chris Roerig
- Address
- 6 Oasis Park Eynsham GB OX29 4tp OX29 4tp
FDA Registration Numbers#
- 3003138182
- 3011310592
- 2113281
Source Documents#
Other 510(k) Records For Product Code NAS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K150163 | Otowave 202 Portable Tympanometer | Amplivox, Ltd. | 2015-04-23 |
Legacy Summary#
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FDA Review#
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