K150657 is an FDA 510(k) clearance for the Phoenix XL Dialysate Meter. This device is classified as a Meter, Conductivity, Non-remote (Class II - Special Controls, product code FIZ).
Submitted by Mesa Laboratories, Inc. (Lakewood, US). The FDA issued a Cleared decision on September 21, 2015, 192 days after receiving the submission on March 13, 2015.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K150657 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 13, 2015 |
| Decision Date | September 21, 2015 |
| Days to Decision | 192 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FIZ - Meter, Conductivity, Non-remote |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |