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510(k) K190775

The RHEA Vital Sign Vigilance System by Shenzhen Fiber Medical Technology Co. , Ltd. — Product Code BZQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2019
Date Received
March 26, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Breathing Frequency
Device Class
Class II
Regulation Number
868.2375
Review Panel
AN
Submission Type

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