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510(k) K141811

MORTARA MONITORING WAVEFORM VIEWER by Mortara Instrument, Inc. — Product Code MHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 2014
Date Received
July 7, 2014
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

Other clearances by Mortara Instrument, Inc.

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  • 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)
  • K152626 — H3+ Holter Recorder (February 26, 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)
  • K142105 — ELI 380 ELECTROCARDIOGRAPH (September 5, 2014)

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