LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER, AND LIFEPAK 11 CARDIAC MONITOR

K Number: K945511 · Decision Sep 26, 1995

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321

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Device Name: LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER, AND LIFEPAK 11 CARDIAC MONITOR
K Number: K945511
Device Class: FDA class 2
Clearance Type: Traditional
Regulation Number: 870.5550
Medical Specialty: Cardiovascular
Decision: Substantially Equivalent
Statement or Summary: Summary
Applicant: Physio-Control Corp.
Date Received: November 9, 1994
Decision Date: September 26, 1995
Product Code: MPE
Advisory Committee: Cardiovascular
Review Advisory Committee: CV
Third Party: N

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code	Device Name	Device Class	Medical Specialty
MPE	Auxiliary Power Supply (Acor Dc) For External Transcutaneous Cardiac Pacemaker	FDA class 2	Cardiovascular

K Number	Device Name	Decision Date	Decision
K991910	LIFEPAK 12 BIPHASIC	Sep 3, 1999	Substantially Equivalent - Subject to Tracking Reg.
K990338	NIBP AND CO2 OPTIONS FOR THE PHYSIO-CONTROL LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM	Sep 1, 1999	Substantially Equivalent
K983393	LIFEPAK 500 BIPHASIC	May 5, 1999	Substantially Equivalent - Subject to Tracking Reg.
K973486	LIFE PAK 12	Jan 9, 1998	Substantially Equivalent
K962359	LIFEPAK 300	Nov 6, 1997	Substantially Equivalent
K955854	LIFEPAK 500	Nov 4, 1996	Substantially Equivalent
K953204	PEDIATRIC QUIK-COMBO	Jan 11, 1996	Substantially Equivalent
K951593	LIFEPAK 11	Dec 29, 1995	Substantially Equivalent
K943301	QUIK COMBO	Feb 3, 1995	Substantially Equivalent
K941970	FAST-PATCH	Dec 7, 1994	Substantially Equivalent

Address: 11811 Willows Rd., NE, P.O. Box 97006, Redmond, WA, 98073, United States
Contact: MICHAEL D WILLINGHAM

This FDA 510(k) entry is associated with 0 FEI numbers. Click on an entry to view related FDA registrations.

This FDA 510(k) entry is associated with 0 registration numbers. Click on an entry to view related FDA registrations.

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Applicant

Physio-Control Corp.

Product Code

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