PrevisEA Device— 510(k) K230769

Substantially Equivalent

Entac Medical, Inc.

FDA 510(k) clearance K230769 for PrevisEA Device, Substantially Equivalent on 2023-05-19. Applicant: Entac Medical, Inc..

Clearance details

Applicant: Entac Medical, Inc.
Product code: Code DQD
Advisory panel: Cardiovascular
Date received: 2023-03-20
Decision date: 2023-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

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