The following data is part of a premarket notification filed by Covidien with the FDA for Bedside Respiratory Patient Monitoring System, Bedside Respiratory Patient Monitoring System With Respiration Rate Softw.
| Device ID | K130320 |
| 510k Number | K130320 |
| Device Name: | BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTW |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-08 |
| Decision Date | 2014-02-04 |
| Summary: | summary |