Vital Connect Platform, HealthPatch MD, VitalPatch

Transmitters And Receivers, Physiological Signal, Radiofrequency

VITAL CONNECT, INC.

The following data is part of a premarket notification filed by Vital Connect, Inc. with the FDA for Vital Connect Platform, Healthpatch Md, Vitalpatch.

Pre-market Notification Details

Device IDK152139
510k NumberK152139
Device Name:Vital Connect Platform, HealthPatch MD, VitalPatch
ClassificationTransmitters And Receivers, Physiological Signal, Radiofrequency
Applicant VITAL CONNECT, INC. 900 E. HAMILTON AVENUE, SUITE 500 Campbell,  CA  95008
ContactBonnie Wu
CorrespondentBonnie Wu
VITAL CONNECT, INC. 900 E. HAMILTON AVENUE, SUITE 500 Campbell,  CA  95008
Product CodeDRG  
Subsequent Product CodeDSI
Subsequent Product CodeMHX
CFR Regulation Number870.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-08-03
Decision Date2015-12-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850490007177 K152139 000
00850490007153 K152139 000
00850490007085 K152139 000
00850490007061 K152139 000
20884838085231 K152139 000
20884838064960 K152139 000
20884838064953 K152139 000

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