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510(k) K190683

External Counterpulsation System by Vamed Medical Instrument Co., Ltd. — Product Code DRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 2019
Date Received
March 18, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Counter-Pulsating, External
Device Class
Class II
Regulation Number
870.5225
Review Panel
CV
Submission Type

Other clearances by Vamed Medical Instrument Co., Ltd.

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