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510(k) K172011

LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System) by Hmicro, Inc. — Product Code DRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2018
Date Received
July 3, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class
Class II
Regulation Number
870.2910
Review Panel
CV
Submission Type

Other clearances by Hmicro, Inc.

  • K140096 — HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE (July 24, 2014)

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