FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REPGREEN ULTRAFILTRATION MONITOR
K Number: K790824
·
Decision Jun 27, 1979
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
7
Applicant Total
4
Review Days
57
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Basic Information
- Device Name
- REPGREEN ULTRAFILTRATION MONITOR
- K Number
- K790824
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Cyberex Corp.
- Date Received
- May 1, 1979
- Decision Date
- June 27, 1979
- Product Code
- FIL
- 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 |
|---|---|---|---|
| FIL | System, Dialysate Delivery, Single Pass | FDA class 2 | Gastroenterology, Urology |
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