Definition: These Devices Are Intended To Measure Chlorine Levels In Water.
| Device Type ID | 2150 |
| Device Name | Chlorine Meter |
| 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 Description | Water Purification System For Hemodialysis. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Renal Devices Branch (RNDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.5665 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PSX |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2150 |
| Device | Chlorine Meter |
| Product Code | PSX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Water Purification System For Hemodialysis. |
| CFR Regulation Number | 876.5665 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
HACH COMPANY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |