samaritan Public Access Automated External Defibrillators and Accessories
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) FDA PMA
- Generic Name
- Automated external defibrillators (non-wearable) FDA PMA
Identifiers
- PMA Number
- P160008 FDA PMA
- FDA Product Code
- MKJ FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Legislation / Framework
- 21 CFR Part 870.5310 FDA PMA
- Regulation Number
- 870.5310 FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P, SAM 450P) are Class III automated external defibrillators (non-wearable) designed to deliver an electric shock to restore normal heart rhythm in victims of sudden cardiac arrest. These devices are intended for use by trained personnel, including those with basic life support, advanced life support, or physician-authorized emergency medical response training.
These devices are supplied with either adult or pediatric electrode pads and are intended for use on patients over 8 years old or weighing over 55 lbs (25 kg) with adult pads, or children aged 1–8 years or under 55 lbs (25 kg) with pediatric pads. They are non-sterile, single-use devices and are not MRI-compatible. Authorized under FDA PMA (P160008), they are regulated under 21 CFR 870.5310 and fall under product code MKJ for cardiovascular use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P160008 | Class III | Active |
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Manufacturer
- Manufacturer
- Heartsine Technologies Ltd
- FDA Applicant
- Heartsine Technologies, Ltd.
Sources (1)
- FDA PMA P160008 24 fields · synced Sep 18, 2026