FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
DIMI RRT System
K Number: K193005
·
Decision Aug 28, 2020
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
343
Applicant Total
1
Review Days
305
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Basic Information
- Device Name
- DIMI RRT System
- K Number
- K193005
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5860
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Dialco Medical, Inc.
- Date Received
- October 28, 2019
- Decision Date
- August 28, 2020
- Product Code
- KDI
- 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 |
|---|---|---|---|
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | FDA class 2 | Gastroenterology, Urology |
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