Amco Replacement Battery for Philips Medical Models BT1 and M5070A
FDA 510(k) K091548 · Amco International Manufacturing & Design, Inc.
Submission
- Device name
- Amco Replacement Battery for Philips Medical Models BT1 and M5070A
- Applicant
- Amco International Manufacturing & Design, Inc.
Elizabeth, CO, US - Received
- May 27, 2009
- Decision date
- August 7, 2009
- 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 |
|---|---|---|
| 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 |
| K072596 | Life+Cel or Lifecel Battery Pack, Model 5L500MKJ · Traditional | 01/24/2008SE |
| K071164 | Life+Cel BatteryMHX · Traditional | 12/07/2007SE |
Questions and answers
When was Amco Replacement Battery for Philips Medical Models BT1 and M5070A cleared by the FDA?
Amco Replacement Battery for Philips Medical Models BT1 and M5070A (K091548) received a 510(k) decision of Substantially Equivalent on August 7, 2009, 72 days after the submission was received.
What is the product code of K091548?
The FDA product code is MKJ – Automated External Defibrillators (Non-Wearable), a Class III (high risk) device regulated under 21 CFR 870.5310.