FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
STATIM 6000B Vacuum Autoclave
K Number: K214057
·
Decision Mar 31, 2022
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
183
Applicant Total
11
Review Days
94
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Basic Information
- Device Name
- STATIM 6000B Vacuum Autoclave
- K Number
- K214057
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 880.6880
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Scican , Ltd.
- Date Received
- December 27, 2021
- Decision Date
- March 31, 2022
- Product Code
- FLE
- 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 |
|---|---|---|---|
| FLE | Sterilizer, Steam | FDA class 2 | General Hospital |
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|---|---|---|---|
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| K072466 | STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MODEL 01-702101 | Dec 19, 2007 | Substantially Equivalent |
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