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 | K120773 |
| 510k Number | K120773 |
| Device Name: | NELLCOR BEDSIDE SPO2 PATIENT MONITORING SYSTEM |
| Classification | Oximeter |
| Applicant | Covidien LLC 77325 JOYCE WAY Echo, OR 97826 -. |
| Contact | Charlie Mack |
| Correspondent | Charlie Mack Covidien LLC 77325 JOYCE WAY Echo, OR 97826 -. |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-14 |
| Decision Date | 2012-07-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521173309 | K120773 | 000 |
| 10884521173293 | K120773 | 000 |
| 10884521163454 | K120773 | 000 |
| 10884521171534 | K120773 | 000 |