Philips Medizin Systeme Böblingen GmbH

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

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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

MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) (MHX) (5) ANALYZER, GAS, HALOTHANE, GASEOUS-PHASE (ANESTHETIC CONC.) (CBS) (1) Full-montage Standard Electroencephalograph (GWQ) (1) Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) (MHX) (1) Monitor, uterine contraction, external (for use in clinic) (HFM) (1) SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS (MSX) (1)

Premarket Exempt

No Yes

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PHILIPS IntelliVue MX550 Patient Monitor - 00884838038783 Catalog Number : 866066

Device Description : The IntelliVue MX550 patient monitor is operated primarily via touch screen. It The IntelliVue MX550 patient monitor is operated primarily via touch screen. It has an integrated 15" TFT widescreen touch display and is compatible with the IntelliVue Multi Measurement Module (M3001A)/ IntelliVue X2 (M3002A) and all Multi-Measurement Module Extensions/ IntelliVue MMX (867036)/ IntelliVue X3 (867030). The monitor has 3 module slots built-in, that are compatible with supported IntelliVue single and dual width measurement modules (see Technical Data Sheet for list of supported modules).The IntelliVue MX550 comes with a built-in battery bay as standard (battery not included in base product), built-in comfort handle and integrated power supply in order to make the monitor portable and/or able to operate during short term power failures.

Device Class : 2

Duns Number: 314101143

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

IntelliVue G7m Gas Analyzer Module - 00884838051492 Catalog Number : 866173

Device Description : IntelliVue G7m Anesthesia Gas Module for use with IntelliVue MP40 to MP90 and MX IntelliVue G7m Anesthesia Gas Module for use with IntelliVue MP40 to MP90 and MX500/550/600/700/800 monitors

Device Class : 2

Duns Number: 314101143

Premarket Exempt : No

Product Code : CBS

Prescription Use : Yes

Device Count : 1

PHILIPS IntelliVue BIS Module - 00884838051515 Catalog Number : 866421

Device Class : 2

Duns Number: 314101143

Premarket Exempt : No

Product Code : GWQ

Prescription Use : No

Device Count : 1

PHILIPS IntelliVue Multi Measurement Server SLCP - 00884838055094 Catalog Number : 866462

Device Class : 2

Duns Number: 314101143

Premarket Exempt : No

Product Code : MHX

Prescription Use : No

Device Count : 1

PHILIPS IntelliVue Remote Alarm Device - 00884838057371 Catalog Number : 866406

Device Description : The IntelliVue Remote Alarm Device (866406) provides audible and visual alarm in The IntelliVue Remote Alarm Device (866406) provides audible and visual alarm information at a remote location. It is compatible with the MX series of patient monitors starting with the MX400.

Device Class : 2

Duns Number: 314101143

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

Philips IntelliVue XDS Application - 00884838059313 Catalog Number :

Device Class : 2

Duns Number: 314101143

Premarket Exempt : No

Product Code : MSX

Prescription Use : No

Device Count : 1

PHILIPS IntelliVue MP2 Military - 00884838064904 Catalog Number : 867059

Device Class : 2

Duns Number: 314101143

Premarket Exempt : No

Product Code : MHX

Prescription Use : No

Device Count : 1

PHILIPS Avalon CL Fetal & Maternal Pod - 00884838068179 Catalog Number : 866488

Device Description : The Avalon CL Fetal & Maternal Pod enables the Avalon wearable solution. It is u The Avalon CL Fetal & Maternal Pod enables the Avalon wearable solution. It is used together with the Avalon CL Basestation 866074.

Device Class : 2

Duns Number: 314101143

Premarket Exempt : No

Product Code : HFM

Prescription Use : Yes

Device Count : 1

Philips IntelliVue Patient Monitoring - 00884838070790 Catalog Number : 866470

Device Description : The IntelliVue MX850 Patient Monitor has an optically-bonded 22 inch (547 mm) LC The IntelliVue MX850 Patient Monitor has an optically-bonded 22 inch (547 mm) LCD (TFT) widescreen display with projected capacitive touch technology. It is compatible with various measurement modules and measurement servers. The monitor provides as standard a 100BaseT LAN port, an RS232 port, four USB ports, a basic nurse call relay, and an analog ECG sync output. MX850 also provides two MSL connectors for connecting up to two FMX-4 module racks (either in parallel or serial). Built-in to the front of the display is a Contactless ID and Communication module using RFID technology. Please refer to technical data sheet for more information.

Device Class : 2

Duns Number: 314101143

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

NA - 00884838072145 Catalog Number : 989803142651

Device Description : Mainstream Sensor

Device Class : 2

Duns Number: 314101143

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

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