Chlorine Meter
The Chlorine Meter is a medical device used in the context of dialysis or other hospital water treatment applications to measure chlorine levels in water, ensuring water quality meets safety standards for patient care. It is classified as FDA Class 2 under 21 CFR 876.5665 in the Gastroenterology and Urology specialty, requiring 510(k) premarket notification. Product code PSX; flagged as life-sustaining, reflecting the critical role of water quality monitoring in dialysis patient safety; not an implant.
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Basic Information
- Product Code
- PSX
- Device Class
- FDA class 2
- Regulation Number
- 876.5665
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
Definition
These devices are intended to measure chlorine levels in water.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K162471 | Hach CM130 Chlorine Monitoring System | Mar 30, 2017 | Substantially Equivalent | Hach Company |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.