510(k) K043344

DIALYSIS SERVICES WATER TREATMENT & DISTRIBUTION SYSTEM by Dialysis Services, Inc. — Product Code FIP

K043344 is an FDA 510(k) premarket notification submitted by Dialysis Services, Inc. for the device "DIALYSIS SERVICES WATER TREATMENT & DISTRIBUTION SYSTEM". The FDA issued a decision of Substantially Equivalent on March 23, 2005. The device falls under product code FIP (Subsystem, Water Purification), a Class II device regulated under 21 CFR 876.5665. Dialysis Services, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 2005
Date Received
December 6, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Subsystem, Water Purification
Device Class
Class II
Regulation Number
876.5665
Review Panel
GU
Submission Type