Atlas FDA

MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER

FDA 510(k) clearance K012274 · decided 2002-02-05

Clearance details

K-number
K012274
Device name
MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER
Applicant
Medtronic Physio-Control Corp.
Decision
Substantially Equivalent
Date received
2001-07-19
Decision date
2002-02-05
Days to decision
201 days
Clearance type
Traditional
Product code
LDD
Device class
2
Regulation number
870.5300
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Redmond, WA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
The LIFEPAK 20 defibrillator/monitor is an AC powered external defibrillator with battery recall (Z-0185-2012)Physio Control, Inc.2011-11-16
The LIFEPAK 20 defibrillator/monitor and LIFEPAK 20e. Product part numbers: 3202487-xxx, 3 recall (Z-1722-2011)Physio Control, Inc.2011-03-18
LIFEPAK 20 defibrillator/monitor. Product Part numbers: 3202487-xxx, 3202488-xxx, U3202487 recall (Z-1903-2010)Physio Control, Inc.2010-07-01
Physio-Control Lifepak 20 defibrillator/monitor is intended for the termination of certain recall (Z-2388-2008)Physio Control, Inc.2008-09-21
Physio-Control LIFEPAK 20 defibrillator/monitor, AC powered external defibrillator with ba recall (Z-1050-2008)Physio Control, Inc.2008-03-29
LIFEPAK 20 defibrillator/monitor. The device is an AC powered defibrillator device with ba recall (Z-0886-2007)Medtronic Emergency Response Systems, Inc.2007-07-04
LIFEPAK 20 defibrillator/monitor. The device is an AC powered defibrillator device with ba recall (Z-0925-2007)Medtronic Emergency Response Systems, Inc.2007-06-09
LIFEPAK 20 automatic external defibrillator recall (Z-0295-2007)Medtronic Emergency Response Systems, Inc.2006-12-19
LIFEPAK 20 external defibrillator/monitor recall (Z-1502-06)Medtronic Emergency Response Systems, Inc.2006-09-13
LIFEPAK 20 defibrillator/monitor recall (Z-0711-06)Medtronic Emergency Response Systems, Inc.2006-04-04
QUIK-COMBO pacing/defibrillation/ECG (therapy) cables used with the LIFEPAK 12 defibrillat recall (Z-0116-06)Medtronic Emergency Response Systems, Inc.2005-11-02
standard (hard) paddles used with the LIFEPAK 12 defibrillator/monitor series. recall (Z-0117-06)Medtronic Emergency Response Systems, Inc.2005-11-02
LIFEPAK 20 defbrillator/monitor recall (Z-0984-05)Medtronic Emergency Response Systems, Inc.2005-07-13
LIFEPAK 12 defibrillator/monitor. recall (Z-0938-04)Medtronic Physio Control Corp2004-07-20
DC Power Adapter for use with the LIFEPAK 12 defibrillator/monitor. recall (Z-0971-04)Medtronic Physio Control Corp2004-07-20
LIFEPAK 12 defibrillator/monitor Part Numbers: VLP12-02-000000 through VLP12-02-005003, AV recall (Z-1107-04)Medtronic Physio Control Corp2004-07-20
LIFEPAK 20 defibrillator/monitor. Paddle sets, an optional accessory item, used with the L recall (Z-0294-04)Medtronic Physio Control Corp2004-01-06