Automated External Defibrillators (Non-Wearable)
Basic Information
- Device Name
- Automated External Defibrillators (Non-Wearable)
- Trade Name
- HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P)
- PMA Number
- P160008
- Device Class
- FDA Class 3
- Product Code
- MKJ
- Generic Name
- Automated external defibrillators (non-wearable)
- Regulation Number
- 870.5310
- Medical Specialty
- Cardiovascular
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- January 12, 2017
- Date Received
- March 21, 2016
- Expedited Review
- N
- Docket Number
- 17M-0229
Advisory Committee Statement
Approval for the HeartSine samaritan® PAD 350P (SAM 350P), PAD 360P (SAM 360P), and PAD 450P (SAM 450P) public access automated external defibrillators and battery/electrode accessories. These AEDs are indicated for use on victims of cardiac arrest who are exhibiting the following signs: 1) Unconscious; 2) Not breathing; and 3) Without circulation (without a pulse)The devices are intended for use by personnel who have been trained in their operation. Users should have received training in basic life support/AED, advanced life support or a physician-authorized emergency medical response training program.The devices are indicated for use on patients greater than 8 years old or over 55 lbs. (25 kg) when used with the adult Pad-Pak (Pad-Pak-01 or Pad-Pak-07). They are indicated for use on children between 1 and 8 years of age or up to 55 lbs. (25 kg) when used with the Pediatric-Pak (Pad-Pak-02).
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MKJ | Automated External Defibrillators (Non-Wearable) | FDA class 3 | Cardiovascular |