Matrix Pre-Treatment Controller
FDA 510(k) clearance K161844 · decided 2016-12-13
Clearance details
- K-number
- K161844
- Device name
- Matrix Pre-Treatment Controller
- Applicant
- Better Water, LLC
- Decision
- Substantially Equivalent
- Date received
- 2016-07-05
- Decision date
- 2016-12-13
- Days to decision
- 161 days
- Clearance type
- Abbreviated
- Product code
- FIP
- Device class
- 2
- Regulation number
- 876.5665
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Smyrna, TN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.