FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
BELIMED STEAM STERILIZER MST-V
K Number: K103841
·
Decision Mar 15, 2011
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
183
Applicant Total
5
Review Days
83
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Basic Information
- Device Name
- BELIMED STEAM STERILIZER MST-V
- K Number
- K103841
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 880.6880
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sauter AG
- Date Received
- December 22, 2010
- Decision Date
- March 15, 2011
- 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 |
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Other Clearances by Sauter AG
| K Number | Device Name | ||
|---|---|---|---|
| K141879 | BELIMED STEAM STERILIZER MST-H | Jun 17, 2015 | Substantially Equivalent |
| K060337 | BELIMED STEAM STERILIZER TOP 5000, MODEL 5-5-9 | Mar 8, 2006 | Substantially Equivalent |
| K033538 | BELIMED STEAM STERILIZER TOP 5000, SERIES 4 - 8 | Feb 2, 2004 | Substantially Equivalent |
| K021223 | BELIMED STEAM STERILIZER, MODEL TOP 5000 | Jun 26, 2002 | Substantially Equivalent |