The following data is part of a premarket notification filed by Monarch Medical Technologies, Llc with the FDA for Endotool Iv 1.10.
| Device ID | K200443 |
| 510k Number | K200443 |
| Device Name: | EndoTool IV 1.10 |
| Classification | Calculator, Drug Dose |
| Applicant | Monarch Medical Technologies, LLC 4400 Stuart Andrew Blvd, Suite N Charlotte, NC 28217 |
| Contact | Ann Marie Gaitan |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | NDC |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2020-02-24 |
| Decision Date | 2020-03-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860003340615 | K200443 | 000 |