PHYSIO-CONTROL, INC.

Address:11811 WILLOWS RD., N.E.,Redmond,WA,98052,US

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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) (10)

Premarket Exempt

No Yes

Clear

LIFEPAK 500 Rechargeable Battery Pack - 00681490576154 Catalog Number : 11141-000002

Device Description : ASSY-BATTERY,SLA,4 CELL,D-SIZE,ENG

Device Class : 3

Duns Number: 009251992

Premarket Exempt : No

Product Code : MKJ

Prescription Use : No

Device Count : 1

LISO2,FAA,LITHIUM BATTERY - 00681490576345 Catalog Number : 11141-000014

Device Description : ASSY-BATTERY,LITHIUM,4CELL,DSIZE,ENG,FAA

Device Class : 3

Duns Number: 009251992

Premarket Exempt : No

Product Code : MKJ

Prescription Use : No

Device Count : 1

LIFEPAK® 500 Automated External Defibrillator - 00681490576598 Catalog Number : 99401-000001

Device Description : ASSY-FINAL,LP500

Device Class : 3

Duns Number: 009251992

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

LIFEPAK® 500 Automated External Defibrillator - 00681490577441 Catalog Number : 99401-000042

Device Description : FINAL ASSY - LP500, ENGLISH,NO VOICE

Device Class : 3

Duns Number: 009251992

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

LIFEPAK® 500 Automated External Defibrillator - 00681490577465 Catalog Number : 99401-000127

Device Description : FINAL ASSY-LP500,ENG,NOVOICE

Device Class : 3

Duns Number: 009251992

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

LIFEPAK® 500 Automated External Defibrillator - 00681490577472 Catalog Number : 99401-000130

Device Description : FINAL ASSY-LP500,ENGLISH, VOICE

Device Class : 3

Duns Number: 009251992

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

LIFEPAK® 500 Automated External Defibrillator - 00681490577526 Catalog Number : 99401-000146

Device Description : FINAL ASSY-LP500,ENGLISHVOICE,2 BUTTON OP

Device Class : 3

Duns Number: 009251992

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

LIFEPAK® 500 Automated External Defibrillator - 00681490577533 Catalog Number : 99401-000150

Device Description : FINAL ASSY-LP500,ENGLISHNO VOICE,2 BUTTON OP

Device Class : 3

Duns Number: 009251992

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

LIFEPAK® 500 Automated External Defibrillator - 00681490577557 Catalog Number : 99401-000153

Device Description : FINAL ASSY-LP500,ENGLISHVOICE,3 BUTTON OP

Device Class : 3

Duns Number: 009251992

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

LIFEPAK® 500 Automated External Defibrillator - 00681490577571 Catalog Number : 99401-000164

Device Description : FINAL ASSY-LP500,ENGLISHNO VOICE,3 BUTTON OP

Device Class : 3

Duns Number: 009251992

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

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