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510(k) K191106

C50 and C80 Multi-parameter Patient Monitor by Shenzhen Comen Medical Instruments Co.,Ltd — Product Code MHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2019
Date Received
April 25, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

Other clearances by Shenzhen Comen Medical Instruments Co.,Ltd

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  • K173454 — Multi-parameter Patient Monitor, models C30 (August 16, 2018)

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