The following data is part of a premarket notification filed by Monarch Medical Technologies, Llc with the FDA for Endotool Iv System.
| Device ID | K201619 |
| 510k Number | K201619 |
| Device Name: | EndoTool IV System |
| Classification | Calculator, Drug Dose |
| Applicant | Monarch Medical Technologies, LLC 4400 Stuart Andrew Blvd, Suite N Charlotte, NC 28217 |
| Contact | Ann Marie Gaitan |
| Correspondent | Ann Marie Gaitan Medical Device Academy 4400 Stuart Andrew Blvd., Suite N Charlotte, NC 28217 |
| Product Code | NDC |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-15 |
| Decision Date | 2020-08-07 |