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Chlorine Meter

Page Type
Product Code
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 and Urology
Review Panel
Gastroenterology and Urology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
876.5665
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
Yes
Third Party Review
Not Third Party Eligible

CFR § 876.5665 Water purification system for hemodialysis

§ 876.5665 Water purification system for hemodialysis.

(a) Identification. A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.

(b) Classification. Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

[48 FR 53023, Nov. 23, 1983, as amended at 84 FR 71814, Dec. 30, 2019]

Chlorine Meter

Page Type
Product Code
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 and Urology
Review Panel
Gastroenterology and Urology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
876.5665
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
Yes
Third Party Review
Not Third Party Eligible

CFR § 876.5665 Water purification system for hemodialysis

§ 876.5665 Water purification system for hemodialysis.

(a) Identification. A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.

(b) Classification. Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

[48 FR 53023, Nov. 23, 1983, as amended at 84 FR 71814, Dec. 30, 2019]