Panels › General Hospital › Product code MEC · Class 2
Disinfector, Medical Devices
Regulation 880.6992
0510(k)s in 12 months (2 all time)
2recalls in 12 months (31 all time)
2recalls that name a 510(k)
Top companies in MEC
| Company | 510(k)s | Recalls |
|---|---|---|
| Steris Corporation | 0 | 11 |
| Getinge Disinfection | 0 | 8 |
| Maquet Cardiovascular Us Sales, Llc | 0 | 5 |
| Getinge Usa Sales Inc | 0 | 3 |
| Getinge USA Inc | 0 | 1 |
| Getinge/Castle, Inc. | 0 | 1 |
| Getinge Group Logistics America, LLC | 0 | 1 |
| Hamo USA, Inc. | 1 | 0 |
| Natus Medical Incorporated | 0 | 1 |
| Olympic Medical Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 20, 2008 | K081094 | OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500 Olympic Medical Corp. | MEC |
| Feb 3, 1994 | K911120 | DECONTAMINATING MACHINES, LS-850, LS-76, DW/T-216, T-21 Hamo USA, Inc. | MEC |
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