510(k) K974034 ยท DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
PORTABLE INTENSIVE CARE UNIT
| Applicant | Medical Research Laboratories, Inc., Buffalo Grove IL, US |
| Decision | Substantially Equivalent, Mar 2, 1998 |
| Received | Oct 23, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974034
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 24, 2011 | Welch Allyn Protocol, Inc Welch Allyn PIC 50 Portable Intensive Care System. Model 971081 series.
Designed for use in and out of the hospital. Terminated |
DRO | None listed |
| Jan 19, 2007 | MRL, Inc., A Welch Allyn Company Welch Allyn PIC 50 Portable Intensive Care System, Multi-Parameter Monitor/Defibrillator; a portable 12V internal battery powered defibrillator; Manufactured by MRL Inc., a WelchAllyn Company, 1000 As Terminated |
MJK | None listed |
| Jul 8, 2006 | MRL, Inc., A Welch Allyn Company Welch Allyn PIC 50 Portable Intensive Care System Multi-Parameter Monitor/Defibrillator; a portable, 12V internal battery powered defibrillator; Manufactured by MRL Inc., A Welch Allyn Company, 1000 A Terminated |
MJK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.