510(k) K021168 ยท MKJ Automated External Defibrillators (Non-Wearable)
JUMP START, MODEL 970300
| Applicant | Medical Research Laboratories, Inc., Buffalo Grove IL, US |
| Decision | Substantially Equivalent - Subject to Tracking Reg., Jun 26, 2002 |
| Received | Apr 11, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021168
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 6, 2009 | Welch Allyn Protocol, Inc Welch Allyn AED 10 automatic external defibrillator and MRL Jumpstart (collectively "AED 10") Terminated |
MKJ | None listed |
| Jun 23, 2009 | Welch Allyn Protocol, Inc Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED 10") Terminated |
MKJ | None listed |
| Mar 10, 2009 | Welch Allyn Protocol, Inc Welch Allyn AED 10 Automated External Defibrillator Terminated |
MKJ | None listed |
| Mar 10, 2009 | Welch Allyn Protocol, Inc Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED 10") Terminated |
MKJ | None listed |
| Mar 9, 2009 | Welch Allyn Protocol, Inc Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED 10") Terminated |
MKJ | None listed |
| Nov 6, 2007 | Welch Allyn Protocol, Inc Welch Allyn AED 10, Automated External Defibrillator, a portable 12V internal battery powered defibrillator; Model AED10; Part Numbers: 970302E,970308E,970309E, 970310E and 970311E; Terminated |
MKJ | None listed |
| Jul 20, 2004 | MRL, Inc., A Welch Allyn Company Welch Allyn AED 10 Defibrillator; a battery powered automated external defibrillator; Manufacturer: MRL, Inc., A Welch Allyn Company, 100 Asbury Drive, Buffalo Grove, Illinois 60089; Model AED10, part Terminated |
MKJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.