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FDA 510(k)

VitalPatch® VitalConnect Platform

K-Number: K163453 · 2017-11-02

ApplicantVitalconnect, Inc.
Decision Date2017-11-02
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VitalPatch® VitalConnect Platform is the device name listed in this FDA 510(k) record. The listed applicant is Vitalconnect, Inc.. It received FDA 510(k) clearance on 2017-11-02 under 510(k) number K163453. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VitalPatch® VitalConnect Platform?

VitalPatch® VitalConnect Platform is a medical device that received FDA 510(k) clearance on 2017-11-02. The listed applicant is Vitalconnect, Inc.. The 510(k) number is K163453.

When did VitalPatch® VitalConnect Platform receive FDA 510(k) clearance?

VitalPatch® VitalConnect Platform received FDA 510(k) clearance on 2017-11-02, under 510(k) number K163453.

Who is the listed applicant for VitalPatch® VitalConnect Platform?

The FDA 510(k) record lists Vitalconnect, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VitalPatch® VitalConnect Platform?

The FDA product code for VitalPatch® VitalConnect Platform is DRG.

Other records listing Vitalconnect, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242129VitalRhythmK193343Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed)K192757VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor – bag of 20, VitalPatch 7D Biosensor – bag of 20K190916VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20K183078VitalConnect Platform, VitalPatch BiosensorK170973VitalWatch Software User Interface

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Related Devices (Code: DRG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.K252984Perin Health System (PHD80060-2)Perin Health Devices, LLCK252440EasyTeleMed (2.0.2)Ingeniars S.R.L.K250259TeleRehab Aermos Cardiopulmonary RehabilitationThe ScottCare CorporationK243837iBSMIorbit Digital Technologies Private LimitedK242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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