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510(k) K173591

Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas by Spectrum Medical , Ltd. — Product Code DRY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2018
Date Received
November 21, 2017
Clearance Type
Traditional
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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