FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFIED BIO. HEMODIALYSIS & HD-1000 DISP. CART.
K Number: K870270
·
Decision Feb 25, 1987
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
18
Applicant Total
3
Review Days
29
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Basic Information
- Device Name
- MODIFIED BIO. HEMODIALYSIS & HD-1000 DISP. CART.
- K Number
- K870270
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5600
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Ash Medical Systems, Inc.
- Date Received
- January 27, 1987
- Decision Date
- February 25, 1987
- Product Code
- FKT
- 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 |
|---|---|---|---|
| FKT | System, Dialysate Delivery, Sorbent Regenerated | FDA class 2 | Gastroenterology, Urology |
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