TAV System— 510(k) K152664

Substantially Equivalent

New Aera, Inc.

FDA 510(k) clearance K152664 for TAV System, Substantially Equivalent on 2016-12-02. Applicant: New Aera, Inc.. Device class: 2.

Clearance details

Applicant: New Aera, Inc.
Product code: Code ONZ
Device class: Class 2
Regulation: 21 CFR 868.5895
Advisory panel: Anesthesiology
Date received: 2015-09-17
Decision date: 2016-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Ramon, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.