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510(k) K131904

MEDIQA SINGLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION, MEDIQA DOUBLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SA by Ameriwater — Product Code FIP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 2013
Date Received
June 25, 2013
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

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  • K021560 — MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS (August 14, 2003)
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