510(k) K920413 ยท MDZ Cleaners, Medical Devices
DECOMAT A 8666
| Applicant | Getinge International, Inc., Lakewood NJ, US |
| Decision | Substantially Equivalent, Apr 5, 1994 |
| Received | Jan 31, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K920413
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 5, 2003 | Getinge/Castle, Inc. Model 8666 Washer/Disinfector with holding tank heater option. Firm on label is Getinge Disinfection AB, Vaxjo, Sweden. Terminated |
MEC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.