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510(k) K051620

MATRIX DIGITAL REVERSE OSMOSIS WATER TREATMENT SYSTEM, MODEL EQRMD SERIES by Better Water, Inc. — Product Code FIP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2005
Date Received
June 17, 2005
Clearance Type
Abbreviated
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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  • K954928 — PORTABLE REVERSE OSMOSIS MACHINE (January 24, 1996)
  • K920186 — WATER PURIFICATION SYSTEM FOR HEMODIALYSIS (June 13, 1995)

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