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510(k) K181923

Quantum Workstation 12.1 by Spectrum Medical , Ltd. — Product Code DRY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2018
Date Received
July 18, 2018
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4330
Review Panel
CV
Submission Type

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