The following data is part of a premarket notification filed by Covidien, Llc with the FDA for Invos Pm7100 Patient Monitor, Invos Pediatric Rso2 Sensor, Invos Infant Regional Saturation Sensor (also Referred To As Oxyalert Nirsensor).
| Device ID | K211561 |
| 510k Number | K211561 |
| Device Name: | INVOS PM7100 Patient Monitor, INVOS Pediatric RSO2 Sensor, INVOS Infant Regional Saturation Sensor (also Referred To As OxyAlert NIRSensor) |
| Classification | Oximeter, Tissue Saturation |
| Applicant | Covidien, Llc 6135 Gunbarrel Avenue Boulder, CO 80301 |
| Contact | Megan Elliott |
| Correspondent | Megan Elliott Covidien, Llc 6135 Gunbarrel Avenue Boulder, CO 80301 |
| Product Code | MUD |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-20 |
| Decision Date | 2021-12-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521832107 | K211561 | 000 |