510(k) K221805

AccurSound Electronic Stethoscope AS-101 by Heroic Faith International , Ltd. — Product Code DQD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 2023
Date Received
June 22, 2022
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