FDA 510(k), K041163, ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES
FDA 510(k), K041163, ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES
Device Name: ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES
Manufacturer: ISOPURE CORP.
Device Classification Name: Subsystem, Water Purification
Regulation Number: 876.5665
Classification Product Code: FIP
Date Received: 05/03/2004
Decision Date: 10/07/2004
Regulation Medical Specialty: Gastroenterology/Urology
Total Pages: 1,065
Fully Redacted Pages: 605
Content Pages: 460
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