Powerheart AED G3 (Model 9390E), Powerheart AED G3 Automatic (Model 9390A)
FDA 510(k) K052161 · Cardiac Science, Inc.
Submission
- Device name
- Powerheart AED G3 (Model 9390E), Powerheart AED G3 Automatic (Model 9390A)
- Applicant
- Cardiac Science, Inc.
Irvine, CA, US - Received
- August 9, 2005
- Decision date
- October 21, 2005
- 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
| 510(k) | Device | Decision |
|---|---|---|
| K143714 | Powerheart G5 AEDMKJ · Traditional | 05/04/2015SE |
| K122758 | Powerheart G5 AEDMKJ · Traditional | 02/12/2014SE |
| K113176 | Mysense HeartDSH · Traditional | 12/21/2011SE |
| K102496 | Powerheart AED G3 Semi-Automatic, Powerheart AED G3 Automatic, Powerheart AED G3 Pro…MKJ · Special | 06/09/2011SE |
| K093211 | Carecenter MDDPS · Traditional | 06/03/2010SE |
| K091943 | Powerheart AED G3, Model 9390E, Powerheart AED G3 Automatic, Model 9390AMKJ · Special | 09/10/2009SE |
| K082090 | 9131 Defibrillation ElectrodesMKJ · Special | 12/12/2008SE |
| K082173 | Q-Stress and Heartstride, Models QSTRESS/Q40 and H4/H4SDPS · Special | 08/26/2008SE |
| K060934 | Modification to Powerheart EcdMKJ · Special | 05/15/2006SE |
| K060167 | Atria 3100, Atria 6100DPS · Abbreviated | 04/19/2006SE |
Questions and answers
When was Powerheart AED G3 (Model 9390E), Powerheart AED G3 Automatic (Model 9390A) cleared by the FDA?
Powerheart AED G3 (Model 9390E), Powerheart AED G3 Automatic (Model 9390A) (K052161) received a 510(k) decision of Substantially Equivalent on October 21, 2005, 73 days after the submission was received.
What is the product code of K052161?
The FDA product code is MKJ – Automated External Defibrillators (Non-Wearable), a Class III (high risk) device regulated under 21 CFR 870.5310.