samaritan PAD 450P
FDA 510(k) K142709 · Heartsine Technologies, Inc.
510(k) numberK142709
Submission
- Device name
- samaritan PAD 450P
- Applicant
- Heartsine Technologies, Inc.
Newton, PA, US - Received
- September 22, 2014
- Decision date
- March 27, 2015
- 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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| K123881 | Heartsine Samaritan Pad 350PMKJ · Traditional | 07/11/2013SE |
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Questions and answers
When was samaritan PAD 450P cleared by the FDA?
samaritan PAD 450P (K142709) received a 510(k) decision of Substantially Equivalent on March 27, 2015, 186 days after the submission was received.
What is the product code of K142709?
The FDA product code is MKJ – Automated External Defibrillators (Non-Wearable), a Class III (high risk) device regulated under 21 CFR 870.5310.