PrevisEA Device— 510(k) K211068

Substantially Equivalent

Entac Medical, Inc.

FDA 510(k) clearance K211068 for PrevisEA Device, Substantially Equivalent on 2021-08-04. Applicant: Entac Medical, Inc..

Clearance details

Applicant: Entac Medical, Inc.
Product code: Code DQD
Advisory panel: Cardiovascular
Date received: 2021-04-12
Decision date: 2021-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

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