FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DECONTAMINATING MACHINES, LS-850, LS-76, DW/T-216, T-21
K Number: K911120
·
Decision Feb 3, 1994
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
1
Applicant Total
1
Review Days
1060
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- DECONTAMINATING MACHINES, LS-850, LS-76, DW/T-216, T-21
- K Number
- K911120
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6992
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Hamo USA, Inc.
- Date Received
- March 11, 1991
- Decision Date
- February 3, 1994
- Product Code
- MEC
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MEC | Disinfector, Medical Devices | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MEC), ordered by most recent decision date.
View all