Aedefibrillator
FDA 510(k) K002232 · Medical Research Laboratories, Inc.
510(k) numberK002232
Submission
- Device name
- Aedefibrillator
- Applicant
- Medical Research Laboratories, Inc.
Buffalo Grove, IL, US - Received
- July 24, 2000
- Decision date
- December 6, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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Questions and answers
When was Aedefibrillator cleared by the FDA?
Aedefibrillator (K002232) received a 510(k) decision of Substantially Equivalent on December 6, 2000, 135 days after the submission was received.
What is the product code of K002232?
The FDA product code is MKJ – Automated External Defibrillators (Non-Wearable), a Class III (high risk) device regulated under 21 CFR 870.5310.