The following data is part of a premarket notification filed by Monarch Medical Technologies with the FDA for Endo Tool Glucose Management System (egms).
| Device ID | K132547 |
| 510k Number | K132547 |
| Device Name: | ENDO TOOL GLUCOSE MANAGEMENT SYSTEM (EGMS) |
| Classification | Calculator, Drug Dose |
| Applicant | MONARCH MEDICAL TECHNOLOGIES 3457 CHISWICK COURT Silver Spring, MD 20906 |
| Contact | Ann A Graham |
| Correspondent | Ann A Graham MONARCH MEDICAL TECHNOLOGIES 3457 CHISWICK COURT Silver Spring, MD 20906 |
| Product Code | NDC |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-13 |
| Decision Date | 2014-04-17 |
| Summary: | summary |