K132547 is an FDA 510(k) clearance for the ENDO TOOL GLUCOSE MANAGEMENT SYSTEM (EGMS). This device is classified as a Calculator, Drug Dose (Class II - Special Controls, product code NDC).
Submitted by Monarch Medical Technologies (Silver Spring, US). The FDA issued a Cleared decision on April 17, 2014, 247 days after receiving the submission on August 13, 2013.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 868.1890.
| 510(k) Number | K132547 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 13, 2013 |
| Decision Date | April 17, 2014 |
| Days to Decision | 247 days |
| Submission Type | Abbreviated |
| 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 |