The following data is part of a premarket notification filed by Covidien Llc with the FDA for Nellcor Portable Spo2 Patient Monitoring System ( Npspms ).
| Device ID | K141542 |
| 510k Number | K141542 |
| Device Name: | NELLCOR PORTABLE SPO2 PATIENT MONITORING SYSTEM ( NPSPMS ) |
| Classification | Oximeter |
| Applicant | Covidien LLC 6135 Gunbarrel Ave Boulder, CO 80301 |
| Contact | Mia M Ware |
| Correspondent | Mia M Ware 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 | 2014-06-10 |
| Decision Date | 2014-10-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521208780 | K141542 | 000 |
| 10884521215962 | K141542 | 000 |
| 10884521215955 | K141542 | 000 |
| 10884521215948 | K141542 | 000 |
| 10884521215931 | K141542 | 000 |