Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Otowave 302 Portable Tympanometer

K-Number: K171265 · 2017-07-28

ApplicantAmplivox, Ltd.
Decision Date2017-07-28
Product CodeNAS
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Otowave 302 Portable Tympanometer is a medical device manufactured by Amplivox, Ltd.. It received FDA 510(k) clearance on 2017-07-28 under approval number K171265. The device is classified under product code NAS. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Otowave 302 Portable Tympanometer?

Otowave 302 Portable Tympanometer is a medical device that received FDA 510(k) clearance on 2017-07-28. It is manufactured by Amplivox, Ltd.. The 510(k) number is K171265.

When was Otowave 302 Portable Tympanometer approved by the FDA?

Otowave 302 Portable Tympanometer received FDA 510(k) clearance on 2017-07-28, under approval number K171265.

What company makes Otowave 302 Portable Tympanometer?

Otowave 302 Portable Tympanometer is manufactured by Amplivox, Ltd..

What is the FDA product code for Otowave 302 Portable Tympanometer?

The FDA product code for Otowave 302 Portable Tympanometer is NAS.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑