K200443 is an FDA 510(k) clearance for the EndoTool IV 1.10. This device is classified as a Calculator, Drug Dose (Class II - Special Controls, product code NDC).
Submitted by Monarch Medical Technologies, LLC (Charlotte, US). The FDA issued a Cleared decision on March 17, 2020, 22 days after receiving the submission on February 24, 2020.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 868.1890.
| 510(k) Number | K200443 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 24, 2020 |
| Decision Date | March 17, 2020 |
| Days to Decision | 22 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | NDC - Calculator, Drug Dose |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1890 |