The following data is part of a premarket notification filed by Mesa Laboratories, Inc. with the FDA for Smarthdm-510 System.
| Device ID | K201765 |
| 510k Number | K201765 |
| Device Name: | SmartHDM-510 System |
| Classification | Meter, Conductivity, Non-remote |
| Applicant | Mesa Laboratories, Inc. 12100 West 6th Ave. Lakewood, CO 80228 |
| Contact | Jamie Louie |
| Correspondent | Johannes Pfingstmann IBP Medical GmbH Ikarusallee 15 Hannover, DE 30179 |
| Product Code | FIZ |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-29 |
| Decision Date | 2020-09-02 |