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510(k) K230698

Anivia SG1000 Pump Console by Apmtd, Inc. — Product Code DWA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 2023
Date Received
March 13, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Control, Pump Speed, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4380
Review Panel
CV
Submission Type

Other clearances by Apmtd, Inc.

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