FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES
K Number: K041163
·
Decision Oct 7, 2004
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
116
Applicant Total
5
Review Days
157
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Basic Information
- Device Name
- ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES
- K Number
- K041163
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5665
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Isopure, Corp.
- Date Received
- May 3, 2004
- Decision Date
- October 7, 2004
- 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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Other Clearances by Isopure, Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K191093 | Isopure Dry Acid Dissolution System | Jan 22, 2020 | Substantially Equivalent |
| K120005 | ACDS | Mar 29, 2012 | Substantially Equivalent |
| K112427 | BICARB MIXING AND DISTRIBUTION SYSTEM | Jan 26, 2012 | Substantially Equivalent |
| K993200 | MD 420/440/460/470/480/490 | Jan 24, 2000 | Substantially Equivalent |