PHILIPS ELECTRONICS NORTH AMERICA CORPORATION

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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

Automated External Defibrillators (Non-Wearable) (MKJ) (8) Electrode, Electrodcardiograph, Multi-Function (MLN) (3) Automated external defibrillators (non-wearable) (MKJ) (2)

Premarket Exempt

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PHILIPS HeartStart FRx - 00884838006560 Catalog Number : 861304

Device Description : HeartStart FRx Defibrillator

Device Class : 3

Duns Number: 079503890

Premarket Exempt : No

Product Code : MKJ

Prescription Use : No

Device Count : 1

PHILIPS HeartStart SMARTPADS II - 00884838023703 Catalog Number : 989803139261

Device Description : HeartStart SMART Pads II

Device Class : 2

Duns Number: 079503890

Premarket Exempt : No

Product Code : MKJ

Prescription Use : No

Device Count : 1

PHILIPS FR/FR2/FR2+ Adult Electrode Pads - 00884838023710 Catalog Number :

Device Description : 1-pack HS FR/FR2 Defib Pads (DP2/DP6)

Device Class : 3

Duns Number: 079503890

Premarket Exempt : No

Product Code : MKJ

Prescription Use : No

Device Count : 1

PHILIPS FR/FR2/FR2+ Adult Electrode Pads - 00884838023727 Catalog Number : 989803158221

Device Class : 3

Duns Number: 079503890

Premarket Exempt : No

Product Code : MKJ

Prescription Use : No

Device Count : 1

PHILIPS FR2/FR2+ Infant/Child Defibrillation Pads - 00884838023734 Catalog Number :

Device Description : FR2 AED Pediatric Defibrillation Pads

Device Class : 2

Duns Number: 079503890

Premarket Exempt : No

Product Code : MLN, MKJ

Prescription Use : No

Device Count : 1

PHILIPS HeartStart Adult SMART Pads - 00884838023741 Catalog Number :

Device Description : HS1 Adult SMART Pads Cartridge

Device Class : 3

Duns Number: 079503890

Premarket Exempt : No

Product Code : MKJ

Prescription Use : No

Device Count : 1

PHILIPS HeartStart Infant/Child SMART Pads - 00884838023758 Catalog Number :

Device Description : HS1 Infant/Child SMART Pads Cartridge

Device Class : 3

Duns Number: 079503890

Premarket Exempt : No

Product Code : MKJ

Prescription Use : No

Device Count : 1

PHILIPS HeartStart SMARTPADS III - 00884838023765 Catalog Number : 989803149981

Device Description : SMART Pads III, 1 set

Device Class : 3

Duns Number: 079503890

Premarket Exempt : No

Product Code : MLN, MKJ

Prescription Use : No

Device Count : 1

PHILIPS HeartStart SMARTPADS III - 00884838023772 Catalog Number :

Device Description : SMART Pads III, 5 sets

Device Class : 3

Duns Number: 079503890

Premarket Exempt : No

Product Code : MLN, MKJ

Prescription Use : No

Device Count : 5

NA - 00884838023789 Catalog Number : 989803136291

Device Class : 3

Duns Number: 079503890

Premarket Exempt : No

Product Code : MKJ

Prescription Use : No

Device Count : 1

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