Cleared Traditional

K162471 - Hach CM130 Chlorine Monitoring System
(FDA 510(k) Clearance)

Mar 2017
Decision
205d
Days
Class 2
Risk

K162471 is an FDA 510(k) clearance for the Hach CM130 Chlorine Monitoring System. This device is classified as a Chlorine Meter (Class II - Special Controls, product code PSX).

Submitted by Hach Company (Ames, US). The FDA issued a Cleared decision on March 30, 2017, 205 days after receiving the submission on September 6, 2016.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5665. These Devices Are Intended To Measure Chlorine Levels In Water..

Submission Details

510(k) Number K162471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2016
Decision Date March 30, 2017
Days to Decision 205 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code PSX — Chlorine Meter
Device Class Class II - Special Controls
CFR Regulation 21 CFR 876.5665
Definition These Devices Are Intended To Measure Chlorine Levels In Water.