The following data is part of a premarket notification filed by Covidien Llc with the FDA for Nellcor Bedside Spo2 Patient Monitoring System.
| Device ID | K142865 |
| 510k Number | K142865 |
| Device Name: | Nellcor Bedside SpO2 Patient Monitoring System |
| Classification | Oximeter |
| Applicant | Covidien LLC 6135 Gunbarrel Ave Boulder, CO 80301 |
| Contact | Megan Fessenden |
| Correspondent | Megan Fessenden Covidien LLC 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 | 2014-09-30 |
| Decision Date | 2015-03-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521527591 | K142865 | 000 |
| 10884521527607 | K142865 | 000 |
| 10884521196728 | K142865 | 000 |