FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
T-Edge 10, T-Edge 11
K Number: K213080
·
Decision Jan 4, 2022
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
183
Applicant Total
4
Review Days
103
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Basic Information
- Device Name
- T-Edge 10, T-Edge 11
- K Number
- K213080
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6880
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tuttnauer , Ltd.
- Date Received
- September 23, 2021
- Decision Date
- January 4, 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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Other Clearances by Tuttnauer , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K222608 | Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS | Dec 16, 2022 | Substantially Equivalent |
| K221227 | Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120 | Sep 20, 2022 | Substantially Equivalent |
| K181456 | Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves | Jul 8, 2019 | Substantially Equivalent |