The following data is part of a premarket notification filed by Covidien Llc with the FDA for Invos Pm7100 Patient Monitor, Invos Adult Rso2 Sensor.
| Device ID | K182868 |
| 510k Number | K182868 |
| Device Name: | INVOS PM7100 Patient Monitor, INVOS Adult RSO2 Sensor |
| Classification | Oximeter, Tissue Saturation |
| Applicant | Covidien Llc 6135 Gunbarrel Avenue Boulder, CO 80301 |
| Contact | Samir Ibrahim |
| Correspondent | Samir Ibrahim 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 | 2018-10-12 |
| Decision Date | 2019-01-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521780101 | K182868 | 000 |
| 10884521780125 | K182868 | 000 |
| 10884521780132 | K182868 | 000 |
| 10884521780149 | K182868 | 000 |
| 10884521780156 | K182868 | 000 |
| 10884521780163 | K182868 | 000 |
| 10884521806436 | K182868 | 000 |
| 10884521809789 | K182868 | 000 |
| 20884521810102 | K182868 | 000 |
| 10884521810112 | K182868 | 000 |
| 10884521552609 | K182868 | 000 |
| 10884521780729 | K182868 | 000 |
| 10884521780170 | K182868 | 000 |
| 20884521556970 | K182868 | 000 |
| 40884521780119 | K182868 | 000 |
| 10884521712805 | K182868 | 000 |
| 10884521780071 | K182868 | 000 |
| 10884521557048 | K182868 | 000 |