510(k) K171265
K171265 is an FDA 510(k) premarket notification submitted by Amplivox, Ltd. for the device "Otowave 302 Portable Tympanometer". The FDA issued a decision of Substantially Equivalent on July 28, 2017. The device falls under product code NAS (Tympanometer), a Class II device regulated under 21 CFR 874.1090. Amplivox, Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 28, 2017
- Date Received
- May 1, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tympanometer
- Device Class
- Class II
- Regulation Number
- 874.1090
- Review Panel
- EN
- Submission Type