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FDA 510(k), K171801, IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable
FDA 510(k), K171801, IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable
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510(K) Number: K171801
Device Name: IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable
Manufacturer: Philips Medizin Systeme Boeblingen GmbH
Device Classification Name: monitor, physiological, patient(with arrhythmia detection or alarms)
Regulation Number: 870.1025
Classification Product Code: MHX
Date Received: 06/16/2017
Decision Date: 10/06/2017
Regulation Medical Specialty: Cardiovascular
Device Name: IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable
Manufacturer: Philips Medizin Systeme Boeblingen GmbH
Device Classification Name: monitor, physiological, patient(with arrhythmia detection or alarms)
Regulation Number: 870.1025
Classification Product Code: MHX
Date Received: 06/16/2017
Decision Date: 10/06/2017
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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