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510(k) K990338

NIBP AND CO2 OPTIONS FOR THE PHYSIO-CONTROL LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM by Physio-Control Corp. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 1999
Date Received
February 3, 1999
Clearance Type
Traditional
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

Other clearances by Physio-Control Corp.

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  • K182503 — Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators (June 3, 2019)
  • K142430 — LIFEPAK 15 monitor/defibrillator (December 19, 2014)
  • K130454 — LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR (August 21, 2013)
  • K123597 — TRUECPR COACHING DEVICE (April 17, 2013)
  • K122600 — LIFEPAK 1000 DEFIBRILLATOR (October 11, 2012)
  • K103567 — LIFEPAK 15 MONITOR/DEFIBRILLATOR (March 22, 2011)
  • K102972 — LIFEPAK 12 (December 22, 2010)
  • K102757 — LIFENET SYSTEM (November 5, 2010)

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