The following data is part of a premarket notification filed by Covidien with the FDA for The Nellcor Pulse Oximetry Monitor Interface Cable.
| Device ID | K172482 |
| 510k Number | K172482 |
| Device Name: | The Nellcor Pulse Oximetry Monitor Interface Cable |
| Classification | Oximeter |
| Applicant | Covidien 6135 Gunbarrel Avenue Boulder, CO 80301 |
| Contact | Mia M. Ware |
| Correspondent | Mia M. Ware Covidien 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 | 2017-08-16 |
| Decision Date | 2017-12-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521705347 | K172482 | 000 |
| 20884521701905 | K172482 | 000 |
| 10884521816015 | K172482 | 000 |
| 10884521816008 | K172482 | 000 |
| 10884521510890 | K172482 | 000 |