The following data is part of a premarket notification filed by Monarch Medical Technologies, Llc with the FDA for Endotool Subq 2.1.
| Device ID | K211160 |
| 510k Number | K211160 |
| Device Name: | EndoTool SubQ 2.1 |
| Classification | Calculator, Drug Dose |
| Applicant | Monarch Medical Technologies, LLC 4400 Stuart Andrew Blvd., Suite N Charlotte, NC 28217 |
| Contact | Ann Marie Gaitan |
| Correspondent | Christophe Mallard Monarch Medical Technologies, LLC 1924 Cleveland Ave, Ste 201 Charlotte, NC 28203 |
| Product Code | NDC |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-19 |
| Decision Date | 2021-10-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860003340622 | K211160 | 000 |