Philips Heartstart Home Defibrillator, Model M5068A
FDA 510(k) K040904 · Philips Medical Systems
Submission
- Device name
- Philips Heartstart Home Defibrillator, Model M5068A
- Applicant
- Philips Medical Systems
Seattle, WA, US - Received
- April 7, 2004
- Decision date
- September 16, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NSA – Over-The-Counter Automated External Defibrillator
- Device class
- Class III (high risk)
- Regulation
- 21 CFR 870.5310
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
Automated external defibrillators are devices that 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 unresponsive and is not breathing normally. The device can be sold over-the-counter without a prescription.…
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Questions and answers
When was Philips Heartstart Home Defibrillator, Model M5068A cleared by the FDA?
Philips Heartstart Home Defibrillator, Model M5068A (K040904) received a 510(k) decision of Substantially Equivalent on September 16, 2004, 162 days after the submission was received.
What is the product code of K040904?
The FDA product code is NSA – Over-The-Counter Automated External Defibrillator, a Class III (high risk) device regulated under 21 CFR 870.5310.