Atlas FDA

PORTABLE INTENSIVE CARE UNIT

FDA 510(k) clearance K974034 · decided 1998-03-02

Clearance details

K-number
K974034
Device name
PORTABLE INTENSIVE CARE UNIT
Applicant
Medical Research Laboratories, Inc.
Decision
Substantially Equivalent
Date received
1997-10-23
Decision date
1998-03-02
Days to decision
130 days
Clearance type
Traditional
Product code
DRO
Device class
2
Regulation number
870.5550
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Buffalo Grove, IL, US
Third-party review
No
Expedited review
No

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RecordFirmDate
LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES (K012218)The Ludlow Company LP2001-10-12
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PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S) (K983196)Tz Medical, Inc.1999-09-15
PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT (K983232)Tz Medical, Inc.1999-09-15
CARDIOSERV P (K962547)Marquette Electronics, Inc.1997-03-06
RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM (K963120)Marquette Electronics, Inc.1997-02-28
ESORT II + 400 SERIES MONITOR (K961138)Medical Data Electronics1996-12-10
ZOLL PD2000 PACEMAKER/ADVISORY DEFIBRILLATOR, MODEL PD2000, ZOLL D2000 ADVISORY DEFIBRILLATOR, MODEL D2000 (K950856)Zoll Medical Corp1995-12-29
LIFEPAK 11 (K951593)Physio-Control Corp.1995-12-29
HEWLETT PACKARD M2475B CODEMASTER 100 DEFIBRILLATOR/MONITOR (K950483)Hewlett-Packard Co.1995-05-22
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Recalls involving this device

RecordFirmDate
Welch Allyn PIC 50 Portable Intensive Care System. Model 971081 series. Designed for use i recall (Z-0937-2011)Welch Allyn Protocol, Inc2011-01-24
Welch Allyn PIC 50 Portable Intensive Care System, Multi-Parameter Monitor/Defibrillator; recall (Z-0343-2007)MRL, Inc., A Welch Allyn Company2007-01-19
Welch Allyn PIC 50 Portable Intensive Care System Multi-Parameter Monitor/Defibrillator; a recall (Z-1195-06)MRL, Inc., A Welch Allyn Company2006-07-08