Philips Medizin Systeme Böblingen GmbH

Address:HEWLETT-PACKARD STRASSE 2,BOEBLINGEN Baden-Wurttemberg,DE

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

SYSTEM, MONITORING, PERINATAL (HGM) (4) MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) (MHX) (3) Oximeter (DQA) (3)

Premarket Exempt

No Yes

Clear

PHILIPS IntelliVue MP5 - 00884838000230 Catalog Number : 865024

Device Description : IntelliVue MP5 Configured Patient Monitor with 8.4" TFT SVGA display. Primary in IntelliVue MP5 Configured Patient Monitor with 8.4" TFT SVGA display. Primary input device is Touch.

Device Class : 2

Duns Number: 314101143

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

PHILIPS IntelliVue Multi Measurement Server - 00884838000254 Catalog Number : 862442

Device Class : 2

Duns Number: 314101143

Premarket Exempt : No

Product Code : DQA

Prescription Use : No

Device Count : 1

PHILIPS IntelliVue Multi Measurement Server X2 - 00884838000261 Catalog Number : 865039

Device Class : 2

Duns Number: 314101143

Premarket Exempt : No

Product Code : MHX

Prescription Use : No

Device Count : 1

PHILIPS IntelliVue MP2 - 00884838000278 Catalog Number : 865040

Device Class : 2

Duns Number: 314101143

Premarket Exempt : No

Product Code : MHX

Prescription Use : No

Device Count : 1

PHILIPS Avalon FM20 Fetal Monitor - 00884838000407 Catalog Number : 862198

Device Description : Avalon FM20 Fetal Monitor for external Fetal Monitoring

Device Class : 2

Duns Number: 314101143

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

PHILIPS Avalon FM30 Fetal Monitor - 00884838000414 Catalog Number : 862199

Device Description : Avalon FM30 Fetal Monitor for all external and internal Fetal Monitoring Applica Avalon FM30 Fetal Monitor for all external and internal Fetal Monitoring Applications including: 1US Transducer and 1 Toco Transducer, MECG Adapter Cable and DECG Reusable Legplate Adapter Cable and the capability of measuring DECG, MECG and IUP

Device Class : 2

Duns Number: 314101143

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

PHILIPS Avalon FM40 Fetal Monitor - 00884838000421 Catalog Number : 865132

Device Description : Avalon FM40 Fetal Monitor for external Fetal Monitoring

Device Class : 2

Duns Number: 314101143

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

PHILIPS Avalon FM50 Fetal Monitor - 00884838000438 Catalog Number : 865071

Device Description : Avalon FM50 Fetal Monitor for all external and internal Fetal Monitoring Applications

Device Class : 2

Duns Number: 314101143

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

NA - 00884838001381 Catalog Number : 989803128631

Device Description : Reusable Clip Adult SpO2 Sensor (3m)

Device Class : 2

Duns Number: 314101143

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

NA - 00884838001398 Catalog Number : 989803128641

Device Description : Reusable Clip Adult SpO2 Sensor (0.9m)

Device Class : 2

Duns Number: 314101143

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

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