FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
STATCLAVE G4 Chamber Autoclave
K Number: K190062
·
Decision Jul 26, 2019
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
183
Applicant Total
11
Review Days
192
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Basic Information
- Device Name
- STATCLAVE G4 Chamber Autoclave
- K Number
- K190062
- 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
- January 15, 2019
- Decision Date
- July 26, 2019
- 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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