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510(k) K202108

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2020
Date Received
July 30, 2020
Clearance Type
Special
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.

  • K190683 — External Counterpulsation System (September 10, 2019)

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