Philips HeartStart AED product approved by FDA. Philips Medical Systems begin selling its HeartStart automatic external defibrillator or AED directly to consumers following the FDA’s Sept. 16 decision to grant the device over-the-counter status (OTC). Removal of the physician prescription requirement makes HeartStart the first AED available directly to consumers.
Product Name:
HeartStart Home Defibrillator (model number M5068A)
Manufacturer:
Philips Medical Systems
Address:
2301 5th Avenue, Suite 200, Seattle, WA 98121
Clearance Date:
September 16, 2004
Clearance Letter:
http://www.fda.gov/cdrh/pdf4/k040904.pdf
Details:
http://www.fda.gov/cdrh/mda/docs/k040904.html
The Design
Philips HeartStart AED was designed to be compact
Teaching Others - how to use.
There are also Philips HeartStart AED Simulator or Trainer which replicate the actual Philips HeartStart AED. With this product available, learning process will become easier and more effective.
Philips HeartStart AED Support Programs.
Successful early defibrillation program requires more than just defibrillators. Philips offers a complete solution that helps us manage the entire spectrum of our AED program, including site assessment, training, data management, regulatory support, medical direction, risk mitigation, and more. With Philips HeartStart Essentials, currently available in the U.S. only, you can rely on a dedicated team of program management specialists to help ensure that your program details are in place and that your organization is prepared in case a sudden cardiac arrest event should occur.
1 comment:
Great Info bro
Ayid
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