The following data is part of a premarket notification filed by Mesa Laboratories, Inc. with the FDA for Phoenix Xl Dialysate Meter.
| Device ID | K150657 |
| 510k Number | K150657 |
| Device Name: | Phoenix XL Dialysate Meter |
| Classification | Meter, Conductivity, Non-remote |
| Applicant | Mesa Laboratories, Inc. 12100 West 6th Avenue Lakewood, CO 80228 |
| Contact | Jamie Louie |
| Correspondent | Jamie Louie Mesa Laboratories, Inc. 12100 West 6th Avenue Lakewood, CO 80228 |
| Product Code | FIZ |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-13 |
| Decision Date | 2015-09-21 |
| Summary: | summary |