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510(k) K202733

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2020
Date Received
September 18, 2020
Clearance Type
Special
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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