The following data is part of a premarket notification filed by Covidien with the FDA for Beside Respiratory Patient Monitoring System Beside Resiratory Patient Monitoring System With Respiration Rate Software.
| Device ID | K121806 |
| 510k Number | K121806 |
| Device Name: | BESIDE RESPIRATORY PATIENT MONITORING SYSTEM BESIDE RESIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTWARE |
| Classification | Oximeter |
| Applicant | COVIDIEN 6135 GUNBARREL AVE. Boulder, CO 80301 |
| Contact | Elizabeth Malo |
| Correspondent | Elizabeth Malo COVIDIEN 6135 GUNBARREL AVE. Boulder, CO 80301 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-20 |
| Decision Date | 2012-09-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521139824 | K121806 | 000 |
| 10884521175945 | K121806 | 000 |
| 10884521171428 | K121806 | 000 |
| 10884521171435 | K121806 | 000 |
| 10884521175952 | K121806 | 000 |
| 10884521139831 | K121806 | 000 |
| 10884521138681 | K121806 | 000 |