Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

VitalConnect Platform, VitalPatch Biosensor

K-Number: K183078 · 2019-03-07

ApplicantVitalconnect, Inc.
Decision Date2019-03-07
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VitalConnect Platform, VitalPatch Biosensor is the device name listed in this FDA 510(k) record. The listed applicant is Vitalconnect, Inc.. It received FDA 510(k) clearance on 2019-03-07 under 510(k) number K183078. 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 VitalConnect Platform, VitalPatch Biosensor?

VitalConnect Platform, VitalPatch Biosensor is a medical device that received FDA 510(k) clearance on 2019-03-07. The listed applicant is Vitalconnect, Inc.. The 510(k) number is K183078.

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

VitalConnect Platform, VitalPatch Biosensor received FDA 510(k) clearance on 2019-03-07, under 510(k) number K183078.

Who is the listed applicant for VitalConnect Platform, VitalPatch Biosensor?

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 VitalConnect Platform, VitalPatch Biosensor?

The FDA product code for VitalConnect Platform, VitalPatch Biosensor 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 20K163453VitalPatch® VitalConnect PlatformK170973VitalWatch Software User Interface

View all 7 devices →

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.

↑