K142918 is an FDA 510(k) clearance for the EndoTool SubQ. This device is classified as a Calculator, Drug Dose (Class II - Special Controls, product code NDC).
Submitted by Monarch Medical Technologies (Charlotte, US). The FDA issued a Cleared decision on April 24, 2015, 199 days after receiving the submission on October 7, 2014.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 868.1890.
| 510(k) Number | K142918 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 07, 2014 |
| Decision Date | April 24, 2015 |
| Days to Decision | 199 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | NDC - Calculator, Drug Dose |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1890 |