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510(k) K183078

VitalConnect Platform, VitalPatch Biosensor by Vitalconnect, Inc. — Product Code DRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 2019
Date Received
November 5, 2018
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 Vitalconnect, Inc.

  • K242129 — VitalRhythm (April 17, 2025)
  • K193343 — Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTabl (April 20, 2020)
  • K192757 — VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5 (February 6, 2020)
  • K190916 — VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20 (June 7, 2019)
  • K163453 — VitalPatch® VitalConnect Platform (November 2, 2017)
  • K170973 — VitalWatch Software User Interface (June 2, 2017)
  • K152139 — Vital Connect Platform, HealthPatch MD, VitalPatch (December 6, 2015)
  • K141167 — VITALCONNECT PLATFORM (CONSISTING OF VITALCONNECT SENSOR, RELAY SOFTWARE LIBRARY (July 29, 2014)
  • K132447 — VITALCONNECT PLATFORM BY VITAL CONNECT INC. (April 3, 2014)

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