FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇬 Singapore
eZSURE Empty Fluid Container
K Number: K252094
·
Decision Aug 1, 2025
Classifications
1
FEI Numbers
86
Registration Numbers
86
Same Product Code
116
Applicant Total
22
Review Days
29
Basic Information
- Device Name
- eZSURE Empty Fluid Container
- K Number
- K252094
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5025
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Epic Medical Pte. , Ltd.
- Date Received
- July 3, 2025
- Decision Date
- August 1, 2025
- 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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|---|---|---|---|
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| K241735 | ProSeal In Line Pump Set (423850) | Oct 10, 2024 | Substantially Equivalent |
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