AEDEFIBRILLATOR
FDA 510(k) clearance K002232 · decided 2000-12-06
Clearance details
- K-number
- K002232
- Device name
- AEDEFIBRILLATOR
- Applicant
- Medical Research Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-07-24
- Decision date
- 2000-12-06
- Days to decision
- 135 days
- Clearance type
- Traditional
- Product code
- MKJ
- Device class
- 3
- Regulation number
- 870.5310
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Buffalo Grove, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery powe recall (Z-1223-2007) | Welch Allyn Protocol, Inc | 2007-09-19 |
| Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery powe recall (Z-1106-06) | MRL, Inc., A Welch Allyn Company | 2006-06-22 |
| Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery powe recall (Z-0806-05) | MRL, Inc., A Welch Allyn Company | 2005-05-12 |