510(k) K162471
K162471 is an FDA 510(k) premarket notification submitted by Hach Company for the device "Hach CM130 Chlorine Monitoring System". The FDA issued a decision of Substantially Equivalent on March 30, 2017. The device falls under product code PSX (Chlorine Meter), a Class II device regulated under 21 CFR 876.5665. Hach Company has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 30, 2017
- Date Received
- September 6, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Chlorine Meter
- Device Class
- Class II
- Regulation Number
- 876.5665
- Review Panel
- GU
- Submission Type
These devices are intended to measure chlorine levels in water.