ClearanceBrief
510(k) K012718 ยท HGM System, Monitoring, Perinatal

MODIFICATION TO COROMETRICS MODEL 120IS MATERNAL/FETAL MONITORING SYSTEM.

ApplicantGe Medical Systems Information Technologies, Wallingford CT, US
DecisionSubstantially Equivalent, Nov 13, 2001
ReceivedAug 15, 2001
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K012718

DateFirm and productCodeLinked 510(k)
Sep 19, 2019Pacific Medical Group Inc.
Pacific Medical GE Corometrics Nautilus Toco Transducer w/knob, 2264HAX, FFCM3205
Open, Classified
HFMNone listed
Sep 19, 2019Pacific Medical Group Inc.
Pacific Medical GE Corometrics Nautilus Toco Transducer w/wing (2264LAX), FFCM3260
Open, Classified
HFMNone listed
Sep 19, 2019Pacific Medical Group Inc.
Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/knob, 5700HAX, FFCM5205
Open, Classified
HGMNone listed
Sep 19, 2019Pacific Medical Group Inc.
Pacific Medical GE Corometrics Nautilus Ultrasound, 5700 (Old Style), FFCM5660
Open, Classified
HGMNone listed
Sep 19, 2019Pacific Medical Group Inc.
Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/wing 5700LAX, FFCM5260
Open, Classified
HGMNone listed
Sep 11, 2019Pacific Medical Group Inc.
Button-Style Tocotransducer (Nautilus), 8-foot Cord 2264HAX, that may have been serviced with the following: Pacific Medical GE Corometrics Nautilus Toco Board, NFCM9310; Pacific Medical GE Corometric
Open, Classified
HFMNone listed
Sep 11, 2019Pacific Medical Group Inc.
Loop-Style Tocotransducer (Nautilus) 2264LAX, that may have been serviced with the following: Pacific Medical GE Corometrics Nautilus Toco Board, NFCM9310; Pacific Medical GE Corometrics Nautilus TOCO
Open, Classified
HFMNone listed
Sep 11, 2019Pacific Medical Group Inc.
Button-Style Ultrasound Transducer (Nautilus), 8-foot Cord 5700HAX, that may have been serviced with the following: Pacific Medical GE Corometrics Nautilus Ultrasound Board, NFCM9510; Pacific Medical
Open, Classified
HGLNone listed
Sep 11, 2019Pacific Medical Group Inc.
Loop-Style Ultrasound Transducer (Nautilus), 8-foot Cord 5700LAX, that may have been serviced with the following: Pacific Medical GE Corometrics Nautilus Ultrasound Board, NFCM9510; Pacific Medical GE
Open, Classified
HGLNone listed
Sep 11, 2019Pacific Medical Group Inc.
External Toco Transducer (M1355A), that may have been serviced with the following: Pacific Medical Philips M1355A Toco Bottom Case, NFPH9315; Pacific Medical Philips M1355A Toco Cable Assembly, NFPH93
Open, Classified
HFMNone listed
Sep 11, 2019Pacific Medical Group Inc.
Ultrasound Transducer (M1356A), that may have been serviced with the following: Pacific Medical Philips M1356A Ultrasound Board, NFPH9510; Pacific Medical Philips M1356A Ultrasound Bottom Case, NFPH95
Open, Classified
HGLNone listed
Sep 11, 2019Pacific Medical Group Inc.
Toco M2734A, that may have been serviced with the following: Pacific Medical Philips Avalon Smart US/TOCO Cable Assembly, NFPHA9020; Pacific Medical Philips Avalon Smart M2734A/2735A Toco Gauge Flex,
Open, Classified
HFMNone listed
Sep 11, 2019Pacific Medical Group Inc.
Toco+ transducer with ECG/IUP capability (wired), that may have been serviced with the following: Pacific Medical Philips Avalon Smart US/TOCO Cable Assembly, NFPHA9020; Pacific Medical Philips Avalon
Open, Classified
HFMNone listed
Sep 11, 2019Pacific Medical Group Inc.
Ultrasound Transducer (M2736A), that may have been serviced with the following: Pacific Medical Philips Avalon Smart US/TOCO Cable Assembly, NFPHA9020; Pacific Medical Philips M2736A Avalon Smart Ultr
Open, Classified
HGLNone listed
Sep 11, 2019Pacific Medical Group Inc.
Toco MP Transducer (M2734B), that may have been serviced with the following: Pacific Medical Philips M2734B Avalon Smart TOCO Bottom Case, NFPHA9315-B
Open, Classified
HFMNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.