FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K Number: K980182
·
Decision Nov 16, 1998
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
116
Applicant Total
3
Review Days
300
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Basic Information
- Device Name
- WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
- K Number
- K980182
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5665
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Usfilter/Ionpure, Inc.
- Date Received
- January 20, 1998
- Decision Date
- November 16, 1998
- Product Code
- FIP
- 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 |
|---|---|---|---|
| FIP | Subsystem, Water Purification | FDA class 2 | Gastroenterology, Urology |
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