FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
Vial Adapter Ø13mm
K Number: K220856
·
Decision Jun 21, 2022
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
205
Applicant Total
1
Review Days
90
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Basic Information
- Device Name
- Vial Adapter Ø13mm
- K Number
- K220856
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Avenir Performance Européenne Medical (Apem)
- Date Received
- March 23, 2022
- Decision Date
- June 21, 2022
- 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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