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510(k) K100127

ELI 230 ELECTROCARDIOGRAPH by Mortara Instrument, Inc. — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2010
Date Received
January 19, 2010
Clearance Type
Abbreviated
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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  • 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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