FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
DIACAP ULTRA DIALYSIS FLUID FILTER
K Number: K052764
·
Decision Jun 9, 2006
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
60
Applicant Total
3
Review Days
252
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Basic Information
- Device Name
- DIACAP ULTRA DIALYSIS FLUID FILTER
- K Number
- K052764
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- B. Braun Medizintechnologie GmbH
- Date Received
- September 30, 2005
- Decision Date
- June 9, 2006
- Product Code
- FKQ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FKQ | System, Dialysate Delivery, Central Multiple Patient | FDA class 2 | Gastroenterology, Urology |
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