The following data is part of a premarket notification filed by Covidien Llc with the FDA for Nellcor Oxysoft Neonatal-adult Spo2 Sensor, Oxysoftn, Nellcor Oxysoft Neonatal-adult Spo2 Sensor, Oxysoftnhc.
| Device ID | K212555 |
| 510k Number | K212555 |
| Device Name: | Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftNHC |
| Classification | Oximeter |
| Applicant | Covidien Llc 6135 Gunbarrel Avenue Boulder, CO 80301 |
| Contact | Anushka Jayaraman |
| Correspondent | Greeshma Kayala Covidien Llc 6135 Gunbarrel Avenue 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 | 2021-08-13 |
| Decision Date | 2022-05-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521819006 | K212555 | 000 |
| 20884521818993 | K212555 | 000 |
| 20884521818979 | K212555 | 000 |
| 20884521818986 | K212555 | 000 |