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510(k) K152944

Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems by Mortara Instrument, Inc. — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 2016
Date Received
October 6, 2015
Clearance Type
Traditional
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)
  • 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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