Hach CM130 Chlorine Monitoring System
FDA 510(k)Class II (US FDA 510(k))
by Hach Company
Identifiers
- 510(k) Number
- K162471 FDA 510(k)
- FDA Product Code
- PSX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5665 FDA 510(k)
- Regulation Number
- 876.5665 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Hach CM130 Chlorine Monitoring System is a device that automatically monitors low levels of total chlorine in pre-treatment water used in dialysis. It measures the total chlorine concentration in dialysate water used for dialysis treatment. The system is designed to provide frequent analysis and immediate notification of high-chlorine events.
The Hach CM130 Chlorine Monitoring System is supplied with a remote indicator for audio and visual notification. It automatically measures chlorine levels at standard intervals, such as every 5 minutes. The device has been authorized with an FDA 510K clearance, with a product code of PSX and a regulation number of 876.5665.
Frequently asked questions
What is the Hach CM130 Chlorine Monitoring System used for?
The Hach CM130 Chlorine Monitoring System is used to automatically monitor low levels of total chlorine in pre-treatment water used in dialysis, measuring the total chlorine concentration in dialysate water.
How often does the Hach CM130 measure chlorine levels?
The Hach CM130 Chlorine Monitoring System automatically measures chlorine levels at standard intervals, such as every 5 minutes.
Is the Hach CM130 supplied with any additional components?
Yes, the Hach CM130 Chlorine Monitoring System is supplied with a remote indicator for audio and visual notification of high-chlorine events.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CM130 Chlorine Monitoring System - Hach, PDF CM130 CHLORINE MONITORING SYSTEM FOR DIALYSIS - hach.com, HACH CM130 USER MANUAL Pdf Download | ManualsLib, PDF CM130 CHLORINE MONITORING SYSTEM FOR DIALYSIS - hach.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K162471 | Class II | Active |
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Manufacturer
- Manufacturer
- Hach Company
Sources (1)
- FDA 510(k) K162471 24 fields · synced Sep 28, 2026