Home / 510(k) Clearances / K190916

510(k) K190916

VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20 by Vitalconnect, Inc. — Product Code DRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 2019
Date Received
April 9, 2019
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)
  • K183078 — VitalConnect Platform, VitalPatch Biosensor (March 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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