The following data is part of a premarket notification filed by Covidien Llc with the FDA for Ge Apexpro Ch Spo2 - Nellcor Cable, Ge Apexpro Fh Spo2 - Nellcor Cable.
| Device ID | K201179 |
| 510k Number | K201179 |
| Device Name: | GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable |
| Classification | Oximeter |
| Applicant | Covidien Llc 6135 Gunbarrel Avenue Boulder, CO 80301 |
| Contact | Ligia Mastronardi |
| Correspondent | Ligia Mastronardi 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 | 2020-05-01 |
| Decision Date | 2020-07-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521780699 | K201179 | 000 |
| 10884521780682 | K201179 | 000 |
| 10884521825642 | K201179 | 000 |