FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇬 Singapore
SMARTez elastomeric infusion pump
K Number: K151650
·
Decision Apr 4, 2016
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
87
Applicant Total
22
Review Days
291
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Basic Information
- Device Name
- SMARTez elastomeric infusion pump
- K Number
- K151650
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Epic Medical Pte. , Ltd.
- Date Received
- June 18, 2015
- Decision Date
- April 4, 2016
- Product Code
- MEB
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MEB | Pump, Infusion, Elastomeric | FDA class 2 | General Hospital |
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|---|---|---|---|
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| K240517 | ProSeal Vented Universal Vial Adaptor | Dec 26, 2024 | Substantially Equivalent |
| K241988 | ProSeal Closed System Bag Access | Oct 23, 2024 | Substantially Equivalent |
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