FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇷 Türkiye
NeutrArt
K Number: K221481
·
Decision Sep 23, 2022
Classifications
1
FEI Numbers
437
Registration Numbers
437
Same Product Code
1167
Applicant Total
3
Review Days
123
Basic Information
- Device Name
- NeutrArt
- K Number
- K221481
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Asset Medikal Tasarim AS.
- Date Received
- May 23, 2022
- Decision Date
- September 23, 2022
- Product Code
- FPA
- 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | FDA class 2 | General Hospital |
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