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510(k) K133989

AMBULO 2400 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM by Mortara Instrument, Inc. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 2014
Date Received
December 26, 2013
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Device Class
Class II
Regulation Number
870.1130
Review Panel
CV
Submission Type

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  • K160685 — Surveyor S4 Mobile Monitor (August 4, 2016)
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  • K152944 — Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing System (January 6, 2016)
  • K141020 — SURVEYOR S4 MOBILE MONITOR (December 3, 2014)
  • K141811 — MORTARA MONITORING WAVEFORM VIEWER (November 19, 2014)
  • K142105 — ELI 380 ELECTROCARDIOGRAPH (September 5, 2014)

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