Philips Medical Systems Hsg

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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

MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) (MHX) (5) ELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS) (MWJ) (2) Thermometer, electronic, clinical (FLL) (2) Automated External Defibrillators (Non-Wearable) (MKJ) (1)

Premarket Exempt

No Yes

Clear

NA - 00884838000018 Catalog Number : M3535A

Device Description : HeartStart MRx monitor/defib

Device Class : 3

Duns Number: 790605856

Premarket Exempt : No

Product Code : MKJ

Prescription Use : No

Device Count : 1

SureSigns VM4 - 00884838000032 Catalog Number : 863063

Device Description : SureSigns VM 4 Patient Monitor

Device Class : 2

Duns Number: 790605856

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

SureSigns VM6 - 00884838000049 Catalog Number : 863064

Device Description : SureSigns VM 6 patient Monitor

Device Class : 2

Duns Number: 790605856

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

SureSigns VM6 - 00884838000056 Catalog Number : 863065

Device Description : SureSigns VM 6 Patient Monitor

Device Class : 2

Duns Number: 790605856

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

SureSigns VM8 - 00884838000063 Catalog Number : 863066

Device Description : SureSigns VM 8 Patient Monitor

Device Class : 2

Duns Number: 790605856

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

SureSigns VM8 - 00884838000087 Catalog Number : 863068

Device Description : SureSigns VM 8 Patient Monitor

Device Class : 2

Duns Number: 790605856

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

Holter Software - 00884838000469 Catalog Number : 860292

Device Class : 2

Duns Number: 790605856

Premarket Exempt : No

Product Code : MWJ

Prescription Use : Yes

Device Count : 1

DigiTrak XT - 00884838000476 Catalog Number : 860322

Device Description : DigiTrak XT Holter Recorder

Device Class : 2

Duns Number: 790605856

Premarket Exempt : No

Product Code : MWJ

Prescription Use : Yes

Device Count : 1

Temperature Probes - 00884838000995 Catalog Number : 21075A

Device Description : Esophageal/Rectal Temperature Probe Reusable; vinyl tip end lead; size = 15 Fr; Esophageal/Rectal Temperature Probe Reusable; vinyl tip end lead; size = 15 Fr; probe length = 10' (3.1m); wgt = l lb (454g)

Device Class : 2

Duns Number: 790605856

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Temperature Probes - 00884838001008 Catalog Number : 21076A

Device Description : Esophageal/Rectal Temperature Probe Reusable; vinyl tip end lead; size 10Fr; pro Esophageal/Rectal Temperature Probe Reusable; vinyl tip end lead; size 10Fr; probe length = 10' (3.1m); wgt = 1 lb (454g)

Device Class : 2

Duns Number: 790605856

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

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