The following data is part of a premarket notification filed by Covidien with the FDA for Nellcor Bedside Respiratory Patient Monitoring System.
| Device ID | K141518 |
| 510k Number | K141518 |
| Device Name: | Nellcor Bedside Respiratory Patient Monitoring System |
| Classification | Oximeter |
| Applicant | COVIDIEN 6135 GUNBARREL AVE. Boulder, CO 80301 |
| Contact | Jamie Thomas |
| Correspondent | Jamie Thomas COVIDIEN 6135 GUNBARREL AVE. Boulder, CO 80301 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-09 |
| Decision Date | 2015-03-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521617299 | K141518 | 000 |
| 10884521182547 | K141518 | 000 |
| 10884521182530 | K141518 | 000 |
| 10884521182523 | K141518 | 000 |
| 10884521182516 | K141518 | 000 |
| 10884521182509 | K141518 | 000 |
| 10884521182493 | K141518 | 000 |