The following data is part of a premarket notification filed by Covidien Llc. with the FDA for Emprint Visualization Application.
| Device ID | K192038 |
| 510k Number | K192038 |
| Device Name: | Emprint Visualization Application |
| Classification | System, Image Processing, Radiological |
| Applicant | Covidien LLC. 5920 Longbow Drive Boulder, CO 80301 |
| Contact | Janna Babson |
| Correspondent | Tim Thomas Covidien LLC 6135 Gunbarrel Avenue Boulder, CO 80301 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-30 |
| Decision Date | 2019-12-02 |