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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 the device name listed in this FDA 510(k) record. The listed applicant is Amplivox, Ltd.. It received FDA 510(k) clearance on 2017-07-28 under 510(k) 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. The listed applicant is Amplivox, Ltd.. The 510(k) number is K171265.

When did Otowave 302 Portable Tympanometer receive FDA 510(k) clearance?

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

Who is the listed applicant for Otowave 302 Portable Tympanometer?

The FDA 510(k) record lists Amplivox, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Official Source

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

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