FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
BELIMED STEAM STERILIZER MODEL TOP 5000 SERIES 24
K Number: K072087
·
Decision Oct 5, 2007
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
183
Applicant Total
3
Review Days
67
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
- BELIMED STEAM STERILIZER MODEL TOP 5000 SERIES 24
- K Number
- K072087
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6880
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Belimed Sauter AG
- Date Received
- July 30, 2007
- Decision Date
- October 5, 2007
- Product Code
- FLE
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FLE | Sterilizer, Steam | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FLE), ordered by most recent decision date.
Enbio PRO
FDA 510(k)
FDA Class 2
·General Hospital
Getinge GSS67N Series Steam Sterilizer
FDA 510(k)
FDA Class 2
·General Hospital
Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer
FDA 510(k)
FDA Class 2
·General Hospital
Cassette Autoclave (ACA5)
FDA 510(k)
FDA Class 2
·General Hospital
Steam Sterilizer (2545D)
FDA 510(k)
FDA Class 2
·General Hospital
FRONT-LINE Field Sterilizer (FL135)
FDA 510(k)
FDA Class 2
·General Hospital