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COROMETRICS 120F SERIES MATERNAL/FETAL MONITOR

FDA premarket approval P000016 · decided 2001-02-09

Approval details

PMA number
P000016
Trade name
COROMETRICS 120F SERIES MATERNAL/FETAL MONITOR
Generic name
Oximeter, fetal pulse
Applicant
Ge Medical Systems Information Technologies
Date received
2000-04-05
Decision date
2001-02-09
Days to decision
310 days
Decision code
APWD
Product code
MMA
Advisory committee
Obstetrics/Gynecology
Expedited review
No
Location
Laurel, MD
Statement
APPROVAL FOR THE COROMETRICS MODEL 120 F-SERIES MATERNAL/FETAL MONITOR WITN INTEGRATED FETAL OXYGEN SATURATION MONITORING, COROMETRICS FETAL PATIENT MOFULE, AND THE NELLCOR OXIFIRST(TM) FS14 SENSOR. THE 120 F-SERIES SYSTEM CONTINUOUSLY MONITORS INTRAPARTUM FETAL OXYGEN SATURATION (FSPO2) AND IS INDICATED AS AN ADJUNCT TO FETAL HEART RATE (FHR) MONITORING IN THE PRESENCE OF A NONREASSURING FETAL HEART RATE PATTERN. IT SHOULD ONLY BE USED AFTER MATERNAL MEMBRANES HAVE RUPTURED AND ON A SINGLETON F

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510(k) clearances by this applicant

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QT GUARD PLUS ANALYSIS SYSTEM (K120770)Ge Medical Systems Information Technologies2012-12-06
CARESCAPE MODEL V100 VITAL SIGNS MONITOR (K102426)Ge Medical Systems Information Technologies2010-10-20
12SL ECG ANALYSIS PROGRAM (K092369)Ge Medical Systems Information Technologies2010-02-24
MARS HOLTER ANALYSIS WORKSTATION (K093141)Ge Medical Systems Information Technologies2009-12-29
CARESCAPE MONITOR B850 (K092027)Ge Medical Systems Information Technologies2009-08-28
MODIFICATION TO DASH 2500 PATIENT MONITOR (K090702)Ge Medical Systems Information Technologies2009-04-15
CAPNOSTAT / CAPNOFLEX CO2 SYSTEM (K083750)Ge Medical Systems Information Technologies2009-03-23
MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE (K083639)Ge Medical Systems Information Technologies2009-02-17