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510(k) K230769

PrevisEA Device by Entac Medical, Inc. — Product Code DQD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2023
Date Received
March 20, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stethoscope, Electronic
Device Class
Class II
Regulation Number
870.1875
Review Panel
CV
Submission Type

Other clearances by Entac Medical, Inc.

  • K211068 — PrevisEA Device (August 4, 2021)

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