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 Code | PSX |
Premarket Review |
Renal, Gastrointestinal, Obesity and Transplant Devices
(DHT3A)
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 |