FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIALYSIS DELIVERY SYS., ULTIM. MODEL II
K Number: K770350
·
Decision Mar 8, 1977
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
49
Applicant Total
1
Review Days
14
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Basic Information
- Device Name
- DIALYSIS DELIVERY SYS., ULTIM. MODEL II
- K Number
- K770350
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Vital Systems, Inc.
- Date Received
- February 22, 1977
- Decision Date
- March 8, 1977
- Product Code
- FKP
- 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 |
|---|---|---|---|
| FKP | System, Dialysate Delivery, Single Patient | FDA class 2 | Gastroenterology, Urology |
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