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

CABLE, ELECTRODE (IKD) (4) ELECTROCARDIOGRAPH (DPS) (2) MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) (MHX) (2) CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) (DSA) (1) Oximeter (DQA) (1)

Premarket Exempt

No Yes

Clear

NA - 00884838011953 Catalog Number : 989803136591

Device Description : Sp02 8-pin D-sub Adapter cbl (8pin) Oxi

Device Class : 2

Duns Number: 314101143

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

NA - 00884838011960 Catalog Number : 989803125851

Device Description : 5 Leadset, Grabber, IEC, ICU

Device Class : 2

Duns Number: 314101143

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

NA - 00884838011977 Catalog Number : 989803125871

Device Description : 5 Leadset, Grabber, IEC, OR

Device Class : 2

Duns Number: 314101143

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

NA - 00884838011984 Catalog Number : 989803125891

Device Description : 5 Leadset, Grabber, Chest, IEC

Device Class : 2

Duns Number: 314101143

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

NA - 00884838011991 Catalog Number : 989803125911

Device Description : 5 Leadset, Grabber, Chest, IEC, OR

Device Class : 2

Duns Number: 314101143

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

PHILIPS Avalon Patient Module - 00884838012141 Catalog Number : 989803144241

Device Description : Avalon Patient Module

Device Class : 2

Duns Number: 314101143

Premarket Exempt : No

Product Code : DSA

Prescription Use : Yes

Device Count : 1

NA - 00884838012479 Catalog Number : 989803170171

Device Description : OR 3-Lead ECG Trunk Cable, AAMI/IEC. Trunk can be used for either color code sys OR 3-Lead ECG Trunk Cable, AAMI/IEC. Trunk can be used for either color code system AAMI and IEC. 1 trunk cable per bag. Cable length = 2,7 m (9ft). Use with indicated 3-lead products

Device Class : 2

Duns Number: 314101143

Premarket Exempt : No

Product Code : DPS

Prescription Use : Yes

Device Count : 1

ECG Trunk Cable - 00884838012486 Catalog Number : 989803170181

Device Description : OR 5-Lead ECG Trunk Cable, AAMI/IEC. Trunk can be used for either color code sys OR 5-Lead ECG Trunk Cable, AAMI/IEC. Trunk can be used for either color code system AAMI and IEC. 1 trunk cable per bag. Cable length = 2,7 m (9ft). Use with indicated 3-lead products

Device Class : 2

Duns Number: 314101143

Premarket Exempt : No

Product Code : DPS

Prescription Use : Yes

Device Count : 1

PHILIPS IntelliBridge EC5 ID-Module - 00884838015944 Catalog Number : 865114

Device Description : The IntelliBridge EC5 is a device identification module and port for connecting The IntelliBridge EC5 is a device identification module and port for connecting external medical devices with IntelliBridge EC10.

Device Class : 2

Duns Number: 314101143

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

PHILIPS IntelliBridge EC10 Module - 00884838015951 Catalog Number : 865115

Device Description : The IntelliBridge EC10 module acquires real-time information from bedside device The IntelliBridge EC10 module acquires real-time information from bedside devices e.g. mechanical ventilators, anesthesia machines, and multi-measurement devices for display on Philips IntelliVue patient monitors.

Device Class : 2

Duns Number: 314101143

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

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