Powerheart AED G3 Semi-Automatic, Powerheart AED G3 Automatic, Powerheart AED G3 Pro, Powerheart AED G3 Plus
FDA 510(k) K102496 · Cardiac Science Corporation
Submission
- Device name
- Powerheart AED G3 Semi-Automatic, Powerheart AED G3 Automatic, Powerheart AED G3 Pro, Powerheart AED G3 Plus
- Applicant
- Cardiac Science Corporation
Bothell, WA, US - Received
- August 31, 2010
- Decision date
- June 9, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MKJ – Automated External Defibrillators (Non-Wearable)
- Device class
- Class III (high risk)
- Regulation
- 21 CFR 870.5310
- Specialty
- Cardiovascular
This device is a non-wearable prescription use only aed. These are devices that include automated external defibrillation. Automated external defibrillators use external pad-type electrodes to sense, detect, classify and treat (with an electrical shock) ventricular fibrillation. These devices are intended to be used on suspected victims of sudden cardiac arrest. A person in cardiac arrest is…
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More from Leonhard Lang GmbH
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| K082090 | 9131 Defibrillation ElectrodesMKJ · Special | 12/12/2008SE |
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| K060934 | Modification to Powerheart EcdMKJ · Special | 05/15/2006SE |
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Questions and answers
When was Powerheart AED G3 Semi-Automatic, Powerheart AED G3 Automatic, Powerheart AED G3 Pro, Powerheart AED G3 Plus cleared by the FDA?
Powerheart AED G3 Semi-Automatic, Powerheart AED G3 Automatic, Powerheart AED G3 Pro, Powerheart AED G3 Plus (K102496) received a 510(k) decision of Substantially Equivalent on June 9, 2011, 282 days after the submission was received.
What is the product code of K102496?
The FDA product code is MKJ – Automated External Defibrillators (Non-Wearable), a Class III (high risk) device regulated under 21 CFR 870.5310.