Cardiac Science 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) (10)

Premarket Exempt

No Yes

Clear

Powerheart® AED G3 Pro AED - 00812394020454 Catalog Number : 9300P-1001SP

Device Description : Stocking package for G3, AED, PRO ,AHA 2010 with adult pads and battery

Device Class : 3

Duns Number: 190713797

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

Powerheart® AED G3 Pro AED - 00812394020461 Catalog Number : 9300P-1101SP

Device Description : G3, AED, PRO ,AHA 2010 with adult pads and rechargeable battery , stocking package

Device Class : 3

Duns Number: 190713797

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

Powerheart® AED G3 Plus Automatic AED, - 00812394020478 Catalog Number : 9390A-1001SP

Device Description : G3Plus, AED, Automatic ,AHA 2010, with adult padsand battery, stocking package

Device Class : 3

Duns Number: 190713797

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

Powerheart® AED G3 Plus Semi Automatic - 00812394020485 Catalog Number : 9390E-1001SP

Device Description : G3Plus, AED, Semi Automatic, AHA 2010, with adultpads and battery, stocking pacakge

Device Class : 3

Duns Number: 190713797

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

Intellisense Adult Defibrillation Pads, Powerheart® G5 - 00812394020492 Catalog Number : XELAED001B

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™ Pediatric Defibrillation Pads Powerheart® G5 - 00812394020515 Catalog Number : XELAED003B

Device Description : Intellisense Pediatric Defibrillation Pads, reduced energy, for Powerheart G5 (u Intellisense Pediatric Defibrillation Pads, reduced energy, for Powerheart G5 (up to 8 years of age or 55 lbs)

Device Class : 3

Duns Number: 190713797

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

Intellisense Adult Defibrillation Pads, CPR Device, Powerheart® G5 - 00812394020522 Catalog Number : XELAED002A

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

Device Class : 3

Duns Number: 190713797

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

AED Manager, V.2.0.5.0 Powerheart G5 - 00812394020539 Catalog Number : XAEDMGR01C

Device Description : Event Reporting and Administrative AED Configuration Software V 2 0 5 0 for Powerheart G5

Device Class : 3

Duns Number: 190713797

Premarket Exempt : No

Product Code : MKJ

Prescription Use : No

Device Count : 1

Powerheart G5 Kit, Auto, US Eng/ESP LA - 00812394020546 Catalog Number : G5A-80A

Device Description : Powerheart G5 AED, Fully Automatic, Dual Language (English/Spanish),with Intelli Powerheart G5 AED, Fully Automatic, Dual Language (English/Spanish),with Intellisense Adult Pads and Battery

Device Class : 3

Duns Number: 190713797

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

Powerheart G5 Kit, Semi, US Eng/ESP LA - 00812394020553 Catalog Number : G5S-80A

Device Description : Powerheart G5 AED, Semi Automatic, Dual Language (English/Spanish),with Intellis Powerheart G5 AED, Semi Automatic, Dual Language (English/Spanish),with Intellisense Adult Pads and Battery

Device Class : 3

Duns Number: 190713797

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

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