TAV System
K-Number: K152664 · 2016-12-02
ApplicantNew Aera, Inc.
Decision Date2016-12-02
Product CodeONZ
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
TAV System is the device name listed in this FDA 510(k) record. The listed applicant is New Aera, Inc.. It received FDA 510(k) clearance on 2016-12-02 under 510(k) number K152664. The device is classified under product code ONZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TAV System?
TAV System is a medical device that received FDA 510(k) clearance on 2016-12-02. The listed applicant is New Aera, Inc.. The 510(k) number is K152664.
When did TAV System receive FDA 510(k) clearance?
TAV System received FDA 510(k) clearance on 2016-12-02, under 510(k) number K152664.
Who is the listed applicant for TAV System?
The FDA 510(k) record lists New Aera, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TAV System?
The FDA product code for TAV System is ONZ.
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.