K050812 is an FDA 510(k) clearance for the 90XL INSTRUMENTATION SYSTEM. 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 May 5, 2005, 35 days after receiving the submission on March 31, 2005.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K050812 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 2005 |
| Decision Date | May 05, 2005 |
| Days to Decision | 35 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FIZ - Meter, Conductivity, Non-remote |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |