510(k) K012718 ยท HGM System, Monitoring, Perinatal
MODIFICATION TO COROMETRICS MODEL 120IS MATERNAL/FETAL MONITORING SYSTEM.
| Applicant | Ge Medical Systems Information Technologies, Wallingford CT, US |
| Decision | Substantially Equivalent, Nov 13, 2001 |
| Received | Aug 15, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012718
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 19, 2019 | Pacific Medical Group Inc. Pacific Medical GE Corometrics Nautilus Toco Transducer w/knob, 2264HAX, FFCM3205 Open, Classified |
HFM | None listed |
| Sep 19, 2019 | Pacific Medical Group Inc. Pacific Medical GE Corometrics Nautilus Toco Transducer w/wing (2264LAX), FFCM3260 Open, Classified |
HFM | None listed |
| Sep 19, 2019 | Pacific Medical Group Inc. Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/knob, 5700HAX, FFCM5205 Open, Classified |
HGM | None listed |
| Sep 19, 2019 | Pacific Medical Group Inc. Pacific Medical GE Corometrics Nautilus Ultrasound, 5700 (Old Style), FFCM5660 Open, Classified |
HGM | None listed |
| Sep 19, 2019 | Pacific Medical Group Inc. Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/wing 5700LAX, FFCM5260 Open, Classified |
HGM | None listed |
| Sep 11, 2019 | Pacific 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 |
HFM | None listed |
| Sep 11, 2019 | Pacific 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 |
HFM | None listed |
| Sep 11, 2019 | Pacific 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 |
HGL | None listed |
| Sep 11, 2019 | Pacific 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 |
HGL | None listed |
| Sep 11, 2019 | Pacific 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 |
HFM | None listed |
| Sep 11, 2019 | Pacific 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 |
HGL | None listed |
| Sep 11, 2019 | Pacific 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 |
HFM | None listed |
| Sep 11, 2019 | Pacific 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 |
HFM | None listed |
| Sep 11, 2019 | Pacific 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 |
HGL | None listed |
| Sep 11, 2019 | Pacific 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 |
HFM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.