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U.S. Department of Health and Human Services

Product Classification
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Device chlorine meter
Regulation Description Water purification system for hemodialysis.
Definition These devices are intended to measure chlorine levels in water.
Physical State An automated or manual sampling system, which can measure chlorine levels in water. Typically used as a component of hemodialysis or water treatment systems but not able to treat or alter the water used in dialysate.
Technical Method Measurement of chlorine levels (free chlorine and/or chloramines) based on a chemical reaction correlation.
Target Area Not used in the body: Used in hospitals and hemodialysis clinics and homes equipped with a water treatment system.
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodePSX
Premarket Review Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
Submission Type 510(k)
Regulation Number 876.5665
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible
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