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510(k) K210669

Quantum Mini Ventilation Module by Spectrum Medical , Ltd. — Product Code DTX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2021
Date Received
March 5, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gas Control Unit, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4300
Review Panel
CV
Submission Type

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