FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6
K Number: K190663
·
Decision Jun 17, 2019
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
8
Applicant Total
44
Review Days
94
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Basic Information
- Device Name
- Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6
- K Number
- K190663
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5130
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- PAJUNK GmbH Medizintechnologie
- Date Received
- March 15, 2019
- Decision Date
- June 17, 2019
- Product Code
- BSN
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BSN | Filter, Conduction, Anesthetic | FDA class 2 | Anesthesiology |
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