FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
Empty EVA Bag
K Number: K193528
·
Decision Jul 22, 2020
Classifications
1
FEI Numbers
86
Registration Numbers
86
Same Product Code
116
Applicant Total
2
Review Days
216
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Basic Information
- Device Name
- Empty EVA Bag
- K Number
- K193528
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5025
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Haemotronic S.P.A.
- Date Received
- December 19, 2019
- Decision Date
- July 22, 2020
- Product Code
- KPE
- 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 |
|---|---|---|---|
| KPE | Container, I.V. | FDA class 2 | General Hospital |
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Other Clearances by Haemotronic S.P.A.
| K Number | Device Name | ||
|---|---|---|---|
| K210749 | Empty EVA Bag | Aug 19, 2021 | Substantially Equivalent |