The following data is part of a premarket notification filed by Covidien with the FDA for Covidien Nellcor Respiration Rate Software Application, Version 1.0.
| Device ID | K111933 |
| 510k Number | K111933 |
| Device Name: | COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICATION, VERSION 1.0 |
| Classification | Monitor, Breathing Frequency |
| Applicant | COVIDIEN 6135 GUNBARREL AVE. Boulder, CO 80301 |
| Contact | Jean Simon |
| Correspondent | Jean Simon COVIDIEN 6135 GUNBARREL AVE. Boulder, CO 80301 |
| Product Code | BZQ |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DSA |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-08 |
| Decision Date | 2012-03-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521103389 | K111933 | 000 |