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510(k) K083287

AVIVO MOBILE PATIENT MANAGEMENT SYSTEM by Corventis, Inc. — Product Code DSI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 2009
Date Received
November 7, 2008
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Detector And Alarm, Arrhythmia
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

Other clearances by Corventis, Inc.

  • K133701 — NUVANT MCT SYSTEM (February 6, 2014)
  • K113372 — NUVANT, MOBILC CARDIAC TELEMETRY (March 7, 2012)
  • K113187 — AVIVO MOBILE PATIENT MANAGEMENT (January 4, 2012)
  • K111917 — NUVANT, MOBILE CARDIAC TELEMETRY (August 24, 2011)
  • K091971 — AVIVO MOBILE PATIENT MANAGEMENT SYSTEM, NUVANT MOBILE CARDIAC TELEMETRY (MCT) SY (August 27, 2009)
  • K090696 — NUVANT CARDIAC EVENT MONITORING SYSTEM; NUVANT MOBILE CARDIAC TELEMETRY SYSTEM (June 19, 2009)

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  • K192732 — BodyGuardian Remote Monitoring System (March 26, 2020)
  • K190574 — Patient Assistant Model PA97000 (September 24, 2019)
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  • K181658 — MobileECG 2 BT (March 26, 2019)