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510(k) K132447

VITALCONNECT PLATFORM BY VITAL CONNECT INC. by Vitalconnect, Inc. — Product Code DRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 2014
Date Received
August 6, 2013
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

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  • 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)

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