Lifepak 500 Biphasic
FDA 510(k) K983393 · Physio-Control Corp.
Submission
- Device name
- Lifepak 500 Biphasic
- Applicant
- Physio-Control Corp.
Redmond, WA, US - Received
- September 25, 1998
- Decision date
- May 5, 1999
- Decision
- Substantially Equivalent - Subject to Tracking Reg. (ST)
- 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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| K123597 | Truecpr Coaching DeviceLIX · Traditional | 04/17/2013SE |
| K122600 | Lifepak 1000 DefibrillatorMKJ · Traditional | 10/11/2012SE |
| K103567 | Lifepak 15 Monitor/DefibrillatorMKJ · Traditional | 03/22/2011SE |
| K102972 | Lifepak 12MKJ · Special | 12/22/2010SE |
| K102757 | Lifenet SystemMSX · Special | 11/05/2010SE |
Questions and answers
When was Lifepak 500 Biphasic cleared by the FDA?
Lifepak 500 Biphasic (K983393) received a 510(k) decision of Substantially Equivalent - Subject to Tracking Reg. on May 5, 1999, 222 days after the submission was received.
What is the product code of K983393?
The FDA product code is MKJ – Automated External Defibrillators (Non-Wearable), a Class III (high risk) device regulated under 21 CFR 870.5310.