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510(k) K142105

ELI 380 ELECTROCARDIOGRAPH by Mortara Instrument, Inc. — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 2014
Date Received
August 1, 2014
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph
Device Class
Class II
Regulation Number
870.2340
Review Panel
CV
Submission Type

Other clearances by Mortara Instrument, Inc.

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  • 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)

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  • K232161 — DeepRhythm Platform (June 20, 2024)