FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
Getinge GSS610N Series Steam Sterilizer
K Number: K201927
·
Decision Mar 1, 2021
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
183
Applicant Total
3
Review Days
234
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Basic Information
- Device Name
- Getinge GSS610N Series Steam Sterilizer
- K Number
- K201927
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6880
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Maquet GmbH
- Date Received
- July 10, 2020
- Decision Date
- March 1, 2021
- 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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