Atlas FDA

MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM

FDA 510(k) clearance K050093 · decided 2005-05-13

Clearance details

K-number
K050093
Device name
MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM
Applicant
Ge Medical Systems Information Technologies
Decision
Substantially Equivalent
Date received
2005-01-14
Decision date
2005-05-13
Days to decision
119 days
Clearance type
Traditional
Product code
DQK
Device class
2
Regulation number
870.1425
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Milwaukee, WI, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Prucka 3 Amplifier Model #P1801PA used with CardioLab AltiX electrophysiology recording sy recall (Z-2258-2024)GE Medical Systems Information Technologies Inc2024-07-03
GE Medical Systems Mac-Lab System, cardiac catheterization data system. Software Version 6 recall (Z-1132-2007)General Electric Medical Systems Information Technology2007-08-07
GE Medical Systems CardioLab System, electrophysiological data system, Software Version 6. recall (Z-1133-2007)General Electric Medical Systems Information Technology2007-08-07
GE Healthcare Systems ComboLab System. Made up of both Mac-Lab System, Software Version 6. recall (Z-1134-2007)General Electric Medical Systems Information Technology2007-08-07

PMA approvals by this applicant

RecordFirmDate
COROMETRICS MODEL 120 F-SERIES MATERNAL/FETAL MONITOR WITH INTERGRATED FETAL OXYGEN SATURATION MONITORING (P000016/S002)Ge Medical Systems Information Technologies2003-10-15
COROMETRICS MODEL 120 SERIES MATERNAL/FETAL MONITOR W/INTEGRATED FETAL PULSE OXIMETRY (P000016/S001)Ge Medical Systems Information Technologies2001-11-09
COROMETRICS 120F SERIES MATERNAL/FETAL MONITOR (P000016)Ge Medical Systems Information Technologies2001-02-09
MODEL 515 NEONATAL MONIOTR (P840037/S001)Ge Medical Systems Information Technologies1986-11-19