The following data is part of a premarket notification filed by Covidien Llc with the FDA for Emprint Procedure Planning Application.
| Device ID | K142048 |
| 510k Number | K142048 |
| Device Name: | EMPRINT PROCEDURE PLANNING APPLICATION |
| Classification | System, Image Processing, Radiological |
| Applicant | Covidien LLC 15 HAMPSHIRE ST Mansfield, MA 02048 |
| Contact | Heather V Nigro |
| Correspondent | Heather V Nigro Covidien LLC 15 HAMPSHIRE ST Mansfield, MA 02048 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-28 |
| Decision Date | 2014-09-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521214026 | K142048 | 000 |
| 10884521214019 | K142048 | 000 |
| 10884521214002 | K142048 | 000 |