Batter Pack, Replacement for Physio Control Lifepak 500
FDA 510(k) K141795 · R & D Batteries, Inc.
Submission
- Device name
- Batter Pack, Replacement for Physio Control Lifepak 500
- Applicant
- R & D Batteries, Inc.
Castle Rock, CO, US - Received
- July 3, 2014
- Decision date
- December 8, 2014
- 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…
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| 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 |
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| 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 |
| K142915 | ZOLL X SeriesMKJ · Traditional | ZOLL Medical Corporation | 12/03/2014SE |
| K142803 | Skintact, various other tradenamesMKJ · Traditional | Leonhard Lang GmbH | 12/02/2014SE |
| K141231 | ZP9141, ZP9146Y, ZP9146W Non-Rechargeable BatteryMKJ · Traditional | Zeller Power Products (Battery Beast, LLC) | 11/25/2014SE |
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| K951404 | R&D Batteries Part Nos. 5096, 5115, 5128 and 5131FLL · Traditional | 08/18/1995SE |
| K951403 | R&D Batteries Part Nos. 5164, 5252, 5634 and 5650FLL · Traditional | 08/18/1995SE |
| K951402 | R&D Batteries Part Nos. 5167, 5221, 5244 and 5247FLL · Traditional | 08/18/1995SE |
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| K951400 | R&D Batteries Part Nos. 5064, 5157, 5489 and 5536FLL · Traditional | 08/18/1995SE |
| K951399 | R&D Batteries Part Nos. 5041 & 5655FLL · Traditional | 08/18/1995SE |
| K951285 | R&D Batteries, Inc. Part Numbers 5158, 5168, 5171 and 5172FLL · Traditional | 08/18/1995SE |
| K951284 | R&D Batteries, Inc. Part Numbers 5137, 5140, 5142 and 5155FLL · Traditional | 08/18/1995SE |
| K951283 | R&D Batteries, Inc. Part Numbers 5075-B, 5076, 5122 and 5123FLL · Traditional | 08/18/1995SE |
| K951282 | R&D Batteries, Inc. Part Numbers 5039, 5052, 5056 and 5061FLL · Traditional | 08/18/1995SE |
Questions and answers
When was Batter Pack, Replacement for Physio Control Lifepak 500 cleared by the FDA?
Batter Pack, Replacement for Physio Control Lifepak 500 (K141795) received a 510(k) decision of Substantially Equivalent on December 8, 2014, 158 days after the submission was received.
What is the product code of K141795?
The FDA product code is MKJ – Automated External Defibrillators (Non-Wearable), a Class III (high risk) device regulated under 21 CFR 870.5310.