Otowave 302 Portable Tympanometer
FDA 510(k) clearance K171265 · decided 2017-07-28
Clearance details
- K-number
- K171265
- Device name
- Otowave 302 Portable Tympanometer
- Applicant
- Amplivox, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2017-05-01
- Decision date
- 2017-07-28
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- NAS
- Device class
- 2
- Regulation number
- 874.1090
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Eynsham, GB
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Amplivox
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Otowave 202 Portable Tympanometer (K150163) | Amplivox, Ltd. | 2015-04-23 |
Recalls involving this device
No recalls on record reference this clearance.