Accessaed, Semi-Automatic External Defibrillators
FDA 510(k) K020984 · Access Cardiosystems, Inc.
Submission
- Device name
- Accessaed, Semi-Automatic External Defibrillators
- Applicant
- Access Cardiosystems, Inc.
Concord, MA, US - Received
- March 18, 2002
- Decision date
- August 14, 2002
- 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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More from Leonhard Lang GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K011461 | Access Cardiosystems Manual DefibrillatorLDD · Traditional | 05/28/2002SE |
Questions and answers
When was Accessaed, Semi-Automatic External Defibrillators cleared by the FDA?
Accessaed, Semi-Automatic External Defibrillators (K020984) received a 510(k) decision of Substantially Equivalent - Subject to Tracking Reg. on August 14, 2002, 149 days after the submission was received.
What is the product code of K020984?
The FDA product code is MKJ – Automated External Defibrillators (Non-Wearable), a Class III (high risk) device regulated under 21 CFR 870.5310.