FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
J.E.T. DIALYSIS SYSTEM
K Number: K820575
·
Decision May 20, 1982
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
4
Applicant Total
4
Review Days
78
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Basic Information
- Device Name
- J.E.T. DIALYSIS SYSTEM
- K Number
- K820575
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Computer Dialysis Systems, Inc.
- Date Received
- March 3, 1982
- Decision Date
- May 20, 1982
- Product Code
- FKJ
- 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 |
|---|---|---|---|
| FKJ | Filter, Blood, Dialysis | FDA class 2 | Gastroenterology, Urology |
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