Product code MEC— General Hospital
DECONTAMINATING MACHINES, LS-850, LS-76, DW/T-216, T-21
- Classification name
- Disinfector, Medical Devices
- Device class
- Class 2
- Regulation
- 21 CFR 880.6992
- Advisory panel
- General Hospital
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code MEC
FDA has cleared devices under product code MEC between 1994 and 2008, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2008
- 1994
Top applicants under product code MEC
Adverse events under product code MEC
product code MEC- Malfunction
- 483
- Other
- 1
- Total
- 484
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code MEC
Data sourced from openFDA. This site is unofficial and independent of the FDA.