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510(k) K160685

Surveyor S4 Mobile Monitor by Mortara Instrument, Inc. — Product Code MHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 2016
Date Received
March 11, 2016
Clearance Type
Traditional
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.

  • 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)
  • 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)
  • K141811 — MORTARA MONITORING WAVEFORM VIEWER (November 19, 2014)
  • K142105 — ELI 380 ELECTROCARDIOGRAPH (September 5, 2014)

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