Reduced Energy Pediatric Electrode Pads for the Samaritan AED and Pad, Models Sde 251, SPP 351
FDA 510(k) K052465 · Heartsine Technologies, Inc.
Submission
- Device name
- Reduced Energy Pediatric Electrode Pads for the Samaritan AED and Pad, Models Sde 251, SPP 351
- Applicant
- Heartsine Technologies, Inc.
Newtown, PA, US - Received
- September 8, 2005
- Decision date
- December 12, 2006
- 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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| K142709 | samaritan PAD 450PMKJ · Traditional | 03/27/2015SE |
| K123881 | Heartsine Samaritan Pad 350PMKJ · Traditional | 07/11/2013SE |
| K042088 | Samaritan Pad Pak Defibrillation Electrode, Model SPP-301MKJ · Traditional | 09/02/2004SE |
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Questions and answers
When was Reduced Energy Pediatric Electrode Pads for the Samaritan AED and Pad, Models Sde 251, SPP 351 cleared by the FDA?
Reduced Energy Pediatric Electrode Pads for the Samaritan AED and Pad, Models Sde 251, SPP 351 (K052465) received a 510(k) decision of Substantially Equivalent on December 12, 2006, 460 days after the submission was received.
What is the product code of K052465?
The FDA product code is MKJ – Automated External Defibrillators (Non-Wearable), a Class III (high risk) device regulated under 21 CFR 870.5310.