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510(k) K182297

Surveyor S2 by Mortara Instrument, Inc. — Product Code DRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 2019
Date Received
August 24, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class
Class II
Regulation Number
870.2910
Review Panel
CV
Submission Type

Other clearances by Mortara Instrument, Inc.

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

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