The following data is part of a premarket notification filed by Monarch Medical Technologies with the FDA for Endotool Subq.
| Device ID | K142918 |
| 510k Number | K142918 |
| Device Name: | EndoTool SubQ |
| Classification | Calculator, Drug Dose |
| Applicant | MONARCH MEDICAL TECHNOLOGIES 2137 SOUTH BLVD. SUITE 300 Charlotte, NC 28203 |
| Contact | Stuart Long |
| Correspondent | Al Pacheco CERTIFIED COMPLIANCE SOLUTIONS 11665 AVENA PLACE, SUITE 203 San Diego, CA 92128 |
| Product Code | NDC |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-07 |
| Decision Date | 2015-04-24 |
| Summary: | summary |