Lifepak 250 Defibrillator/Monitor
FDA 510(k) K892065 · Physio-Control Corp.
510(k) numberK892065
Submission
- Device name
- Lifepak 250 Defibrillator/Monitor
- Applicant
- Physio-Control Corp.
Redmond, WA, US - Received
- March 30, 1989
- Decision date
- June 5, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K102972 | Lifepak 12MKJ · Special | 12/22/2010SE |
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Questions and answers
When was Lifepak 250 Defibrillator/Monitor cleared by the FDA?
Lifepak 250 Defibrillator/Monitor (K892065) received a 510(k) decision of Substantially Equivalent on June 5, 1989, 67 days after the submission was received.
What is the product code of K892065?
The FDA product code is MKJ – Automated External Defibrillators (Non-Wearable), a Class III (high risk) device regulated under 21 CFR 870.5310.