VitalPatch 5D Biosensor - Single, VitalPatch 7D Biosensor - Single, VitalPatch 5D Biosensor – Bag Of 20, VitalPatch 7D Biosensor – Bag Of 20

Transmitters And Receivers, Physiological Signal, Radiofrequency

VitalConnect, Inc.

The following data is part of a premarket notification filed by Vitalconnect, Inc. with the FDA for Vitalpatch 5d Biosensor - Single, Vitalpatch 7d Biosensor - Single, Vitalpatch 5d Biosensor – Bag Of 20, Vitalpatch 7d Biosensor – Bag Of 20.

Pre-market Notification Details

Device IDK192757
510k NumberK192757
Device Name:VitalPatch 5D Biosensor - Single, VitalPatch 7D Biosensor - Single, VitalPatch 5D Biosensor – Bag Of 20, VitalPatch 7D Biosensor – Bag Of 20
ClassificationTransmitters And Receivers, Physiological Signal, Radiofrequency
Applicant VitalConnect, Inc. 224 Airport Parkway, Suite 300 San Jose,  CA  95110
ContactCynthia Merrell
CorrespondentCynthia Merrell
VitalConnect, Inc. 224 Airport Parkway, Suite 300 San Jose,  CA  95110
Product CodeDRG  
Subsequent Product CodeDSI
Subsequent Product CodeMHX
CFR Regulation Number870.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyCardiovascular
510k Review PanelCardiovascular
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-30
Decision Date2020-02-06

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