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510(k) K152626

H3+ Holter Recorder by Mortara Instrument, Inc. — Product Code MWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 2016
Date Received
September 15, 2015
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 Mortara Instrument, Inc.

  • K182297 — Surveyor S2 (January 24, 2019)
  • K173765 — Surveyor Patient Monitor (September 4, 2018)
  • K161517 — Mortara Surveyor Patient Monitor (January 11, 2017)
  • K161465 — CardioConfirm (September 3, 2016)
  • K160685 — Surveyor S4 Mobile Monitor (August 4, 2016)
  • K152944 — Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing System (January 6, 2016)
  • K141020 — SURVEYOR S4 MOBILE MONITOR (December 3, 2014)
  • K133989 — AMBULO 2400 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM (November 25, 2014)
  • K141811 — MORTARA MONITORING WAVEFORM VIEWER (November 19, 2014)
  • K142105 — ELI 380 ELECTROCARDIOGRAPH (September 5, 2014)

Other clearances for product code MWJ

  • K231424 — HeartBeam AIMIGo(TM) System (December 13, 2024)
  • K233864 — ASSURE Wearable ECG (May 7, 2024)
  • K212317 — Eclipse MINI Model 98900 (November 7, 2022)
  • 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)
  • K142424 — DR300 HOLTER MONITOR (November 25, 2014)