Cardiac Science 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) (10)

Premarket Exempt

No Yes

Clear

Powerheart® G5 Semi Automatic AED - 00812394020041 Catalog Number : G5S-01P0

Device Description : Powerheart® G5 Semi-Automatic AED

Device Class : 3

Duns Number: 190713797

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

Powerheart® AED G3 Pro - 00812394020058 Catalog Number : 9300P-01

Device Description : G3, AED, PRO ,AHA 2010

Device Class : 3

Duns Number: 190713797

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

Powerheart® AED G3 Automatic AED - 00812394020065 Catalog Number : 9300A-1001-TSO

Device Description : G3, AED, Automatic, AHA 2010, TSO with adult pads and TSO battery

Device Class : 3

Duns Number: 190713797

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

Powerheart® AED G3 Semi Automatic AED - 00812394020072 Catalog Number : 9300E-1001-TSO

Device Description : G3, AED, Semi-Automatic ,AHA 2010, TSO with adult pads and TSO battery

Device Class : 3

Duns Number: 190713797

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

Powerheart® G3 Pro Rechargeable Battery - 00812394020089 Catalog Number : 9144-101

Device Description : Rechargeable battery: For Powerheart® AED G3 Pro model 9300P with 1 year full re Rechargeable battery: For Powerheart® AED G3 Pro model 9300P with 1 year full replacement guarantee

Device Class : 3

Duns Number: 190713797

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

Powerheart® G3 Pro Battery Charger - 00812394020096 Catalog Number : 9044-100

Device Description : Charger, for rechargeable battery: Powerheart® AED G3 Pro model 9300P

Device Class : 3

Duns Number: 190713797

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

Powerheart® Adult Defibrillation Pads - 00812394020102 Catalog Number :

Device Description : Defibrillation Pads(adult) with two-year shelf life for full range of Powerheart® AEDs

Device Class : 3

Duns Number: 190713797

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

Powerheart® Pro Battery - 00812394020119 Catalog Number : 9145-301

Device Class : 3

Duns Number: 190713797

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

Intellisense Adult Defibrillation Pads, Powerheart® G5 - 00812394020126 Catalog Number : XELAED001A

Device Description : Intellisense Adult defibrillation Pads, non-polarized for Powerheart® G5

Device Class : 3

Duns Number: 190713797

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

Intellisense® Battery Powerheart® G5 - 00812394020133 Catalog Number : XBTAED001A

Device Description : Intellisense non-rechargeable battery for Powerheart G5 AED with 4 year full rep Intellisense non-rechargeable battery for Powerheart G5 AED with 4 year full replacement guarantee.

Device Class : 3

Duns Number: 190713797

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

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