The following data is part of a premarket notification filed by Mesa Laboratories, Inc. with the FDA for 90xl Instrumentation System.
Device ID | K050812 |
510k Number | K050812 |
Device Name: | 90XL INSTRUMENTATION SYSTEM |
Classification | Meter, Conductivity, Non-remote |
Applicant | MESA LABORATORIES, INC. 12100 WEST 6TH AVE. Lakewood, CO 80228 |
Contact | Todd Romero |
Correspondent | Todd Romero MESA LABORATORIES, INC. 12100 WEST 6TH AVE. Lakewood, CO 80228 |
Product Code | FIZ |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-03-31 |
Decision Date | 2005-05-05 |