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510(k) K062233

HEARTSTART MRX MONITOR/DEFIBRILLATOR by Philips Medical Systems North America, Inc. — Product Code MKJ

K062233 is an FDA 510(k) premarket notification submitted by Philips Medical Systems North America, Inc. for the device "HEARTSTART MRX MONITOR/DEFIBRILLATOR". The FDA issued a decision of Substantially Equivalent on November 22, 2006. The device falls under product code MKJ (Automated External Defibrillators (Non-Wearable)), a Class III device regulated under 21 CFR 870.5310. Philips Medical Systems North America, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2006
Date Received
August 2, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Automated External Defibrillators (Non-Wearable)
Device Class
Class III
Regulation Number
870.5310
Review Panel
CV
Submission Type

This device is a non-wearable prescription use only aed. These are devices that include automated external defibrillation. Automated external defibrillators use external pad-type electrodes to sense, detect, classify and treat (with an electrical shock) ventricular fibrillation. These devices are intended to be used on suspected victims of sudden cardiac arrest. A person in cardiac arrest is unresponsive and is not breathing normally. The device can be sold with prescription only.

Other clearances by Philips Medical Systems North America, Inc.

  • K101311 — EP NAVIGATOR R3 (September 30, 2010)
  • K102005 — ALLURA XPER OR TABLE SERIES (August 9, 2010)
  • K090625 — WIRELESS PORTABLE DETECTOR FD-W17 (March 24, 2009)
  • K090590 — VERADIUS, MODEL 718-130 (March 16, 2009)
  • K082280 — SURESIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VM1 PATIENT MONITOR, SURESIGNS VS3 (October 8, 2008)
  • K063781 — PHILIPS XD-S DIRECT RADIOGRAPHY WORKSTATION/PACKAGE (January 5, 2007)
  • K062268 — MASIMO SET SPO2 MODULE FOR PHILIPS AND M3001A MULTI-MEASUREMENT SERVER OPTION A0 (October 18, 2006)
  • K062283 — THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 INTELLIVUE PATIENT MO (September 20, 2006)
  • K061685 — PULSERA (September 15, 2006)
  • K061995 — XCELERA (September 6, 2006)

Other clearances for product code MKJ

  • K143714 — Powerheart G5 AED (May 4, 2015)
  • K150055 — OneStep Pediatric CPR Multi-Function Electrode (May 2, 2015)
  • K150198 — CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel (May 2, 2015)
  • K142709 — samaritan PAD 450P (March 27, 2015)
  • K133659 — HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING (January 23, 2015)
  • K133239 — ZOLL E SERIES (January 16, 2015)
  • K142430 — LIFEPAK 15 monitor/defibrillator (December 19, 2014)
  • K141795 — BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500 (December 8, 2014)
  • K142915 — ZOLL X Series (December 3, 2014)
  • K142803 — Skintact, various other tradenames (December 2, 2014)

FDA data resources