Life+Cel or Lifecel Battery Pack, Model 5L500
FDA 510(k) K072596 · Amco International Manufacturing & Design, Inc.
Submission
- Device name
- Life+Cel or Lifecel Battery Pack, Model 5L500
- Applicant
- Amco International Manufacturing & Design, Inc.
Elizabeth, CO, US - Received
- September 14, 2007
- Decision date
- January 24, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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…
Other 510(k)s with product code MKJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K143714 | Powerheart G5 AEDMKJ · Traditional | Cardiac Science Corporation | 05/04/2015SE |
| K150198 | CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz GelMKJ · Traditional | Bio-Detek, Inc. | 05/02/2015SE |
| K150055 | OneStep Pediatric CPR Multi-Function ElectrodeMKJ · Traditional | Bio-Detek, Inc. | 05/02/2015SE |
| K142709 | samaritan PAD 450PMKJ · Traditional | Heartsine Technologies, Inc. | 03/27/2015SE |
| K133659 | Heartstart Xl+Defibrillator/Monitor with End-Tidal Carbon Dioxide MonitoringMKJ · Traditional | Philips Medical Systems | 01/23/2015SE |
| K133239 | Zoll E SeriesMKJ · Traditional | Zoll Medical Corporation, World Wide Headquarters | 01/16/2015SE |
| K142430 | LIFEPAK 15 monitor/defibrillatorMKJ · Traditional | Physio-Control, Inc. | 12/19/2014SE |
| K141795 | Batter Pack, Replacement for Physio Control Lifepak 500MKJ · Traditional | R & D Batteries, Inc. | 12/08/2014SE |
| K142915 | ZOLL X SeriesMKJ · Traditional | ZOLL Medical Corporation | 12/03/2014SE |
| K142803 | Skintact, various other tradenamesMKJ · Traditional | Leonhard Lang GmbH | 12/02/2014SE |
More from Leonhard Lang GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K091548 | Amco Replacement Battery for Philips Medical Models BT1 and M5070AMKJ · Traditional | 08/07/2009SE |
| K082861 | Amco Replacement Battery for Powerheart AED, Non-Rechargeable, Model 2L561; G3…MKJ · Traditional | 11/25/2008SE |
| K073716 | Life+Cel or Lifecel BatteryMKJ · Traditional | 04/11/2008SE |
| K071164 | Life+Cel BatteryMHX · Traditional | 12/07/2007SE |
Questions and answers
When was Life+Cel or Lifecel Battery Pack, Model 5L500 cleared by the FDA?
Life+Cel or Lifecel Battery Pack, Model 5L500 (K072596) received a 510(k) decision of Substantially Equivalent on January 24, 2008, 132 days after the submission was received.
What is the product code of K072596?
The FDA product code is MKJ – Automated External Defibrillators (Non-Wearable), a Class III (high risk) device regulated under 21 CFR 870.5310.