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510(k) K001349

CARDIOVISE ECG INTERPRETATIVE SOFTWARE by Inovise Medical, Inc. — Product Code MWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 2000
Date Received
April 28, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph, Ambulatory (Without Analysis)
Device Class
Class II
Regulation Number
870.2800
Review Panel
CV
Submission Type

Other clearances by Inovise Medical, Inc.

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  • K130660 — AUDICOR CPAM WITH SDB (SINGLE SENSOR) (October 11, 2013)
  • K120462 — AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED (September 20, 2012)
  • K110569 — AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR) (October 24, 2011)
  • K103516 — AUDICOR SENSOR-ADAPTER MODEL AUDICOR SENSOR-ADAPTER 4.0 (February 4, 2011)
  • K080602 — AUDICOR SENSOR, MODELS: 2.0, 3.0 (September 25, 2008)
  • K073545 — AUDICOR, HEMO AMBULATORY MONITOR (September 9, 2008)
  • K070136 — AUDICOR 200 SYSTEM, MODELS 200D AND 200S (April 13, 2007)
  • K051450 — EXTENDED MEASUREMENTS SYSTEM (November 10, 2005)

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  • K222017 — Biotres (July 28, 2022)
  • K210758 — Q Patch (June 2, 2022)
  • K211709 — Biotres (January 19, 2022)
  • K211651 — Eclipse PRO (November 22, 2021)
  • K173156 — Integrated CardioRespiratory System (June 8, 2018)
  • K161062 — NR Recorder (June 13, 2016)
  • K152626 — H3+ Holter Recorder (February 26, 2016)