The following data is part of a premarket notification filed by Covidien, Llc with the FDA for Emprint Ablation Visualization Application.
| Device ID | K180192 |
| 510k Number | K180192 |
| Device Name: | Emprint Ablation Visualization Application |
| Classification | System, Image Processing, Radiological |
| Applicant | Covidien, LLC 5920 Longbow Dr. Boulder, CO 80301 |
| Contact | Patti L. Arndt |
| Correspondent | Patti L. Arndt Covidien, LLC 5920 Longbow Dr. 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 | 2018-01-24 |
| Decision Date | 2018-03-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521783928 | K180192 | 000 |
| 10884521717411 | K180192 | 000 |