PHILIPS ELECTRONICS NORTH AMERICA CORPORATION

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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

Automated External Defibrillators (Non-Wearable) (MKJ) (9) Over-The-Counter Automated External Defibrillator (NSA) (1)

Premarket Exempt

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PHILIPS HeartStart HOME - 00884838049130 Catalog Number :

Device Description : HeartStart Home Defibrillator, HS1

Device Class : 3

Duns Number: 079503890

Premarket Exempt : No

Product Code : NSA

Prescription Use : No

Device Count : 1

PHILIPS QCPR Meter Cable - 00884838049949 Catalog Number : 989803149951

Device Description : Cable Link, FR3 to Q-CPR Meter

Device Class : 3

Duns Number: 079503890

Premarket Exempt : No

Product Code : MKJ

Prescription Use : No

Device Count : 1

PHILIPS FR2 3-Lead ECG, AAMI - 00884838049956 Catalog Number :

Device Description : FR2 ECG Assessment Module, AAMI

Device Class : 3

Duns Number: 079503890

Premarket Exempt : No

Product Code : MKJ

Prescription Use : No

Device Count : 1

PHILIPS FR2 3-Lead ECG, IEC - 00884838049963 Catalog Number :

Device Description : FR2 ECG Assessment Module

Device Class : 3

Duns Number: 079503890

Premarket Exempt : No

Product Code : MKJ

Prescription Use : No

Device Count : 1

PHILIPS HeartStart FR3 - 00884838049987 Catalog Number : 861388

Device Description : HeartStart FR3 Defibrillator, Text

Device Class : 3

Duns Number: 079503890

Premarket Exempt : No

Product Code : MKJ

Prescription Use : No

Device Count : 1

PHILIPS HeartStart FR3 - 00884838049994 Catalog Number : 861389

Device Description : HeartStart FR3 Defibrillator, ECG

Device Class : 3

Duns Number: 079503890

Premarket Exempt : No

Product Code : MKJ

Prescription Use : No

Device Count : 1

PHILIPS HeartStart FR3 3-Lead ECG, AAMI - 00884838050006 Catalog Number : 989803150041

Device Description : 3-Lead ECG Cable, FR3, AAMI

Device Class : 3

Duns Number: 079503890

Premarket Exempt : No

Product Code : MKJ

Prescription Use : No

Device Count : 1

PHILIPS HeartStart FR2+ with ECG - 00884838050389 Catalog Number : 861458

Device Description : HS Refurbished FR2+ AED, with ECG

Device Class : 3

Duns Number: 079503890

Premarket Exempt : No

Product Code : MKJ

Prescription Use : No

Device Count : 1

PHILIPS HeartStart FR2+ - 00884838050396 Catalog Number : 861459

Device Description : HS Refurbished FR2+ AED, no ECG

Device Class : 3

Duns Number: 079503890

Premarket Exempt : No

Product Code : MKJ

Prescription Use : No

Device Count : 1

PHILIPS HeartStart OnSite - 00884838050679 Catalog Number : 861334

Device Description : Guidelines Update, New HS1

Device Class : 3

Duns Number: 079503890

Premarket Exempt : No

Product Code : MKJ

Prescription Use : No

Device Count : 1

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