FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
E-Z LINK
K Number: K133097
·
Decision Mar 13, 2014
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
205
Applicant Total
3
Review Days
164
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Basic Information
- Device Name
- E-Z LINK
- K Number
- K133097
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Duoject Medical Systems, Inc.
- Date Received
- September 30, 2013
- Decision Date
- March 13, 2014
- Product Code
- LHI
- 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 |
|---|---|---|---|
| LHI | Set, I.V. Fluid Transfer | FDA class 2 | General Hospital |
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