The following data is part of a premarket notification filed by Covidien with the FDA for Vital Sync Informatics Manager & Virtual Patient Monitoring Platform.
| Device ID | K140339 |
| 510k Number | K140339 |
| Device Name: | VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | COVIDIEN 6135 GUNBARREL AVE. Boulder, CO 80301 |
| Contact | Brianna Reynolds |
| Correspondent | Brianna Reynolds COVIDIEN 6135 GUNBARREL AVE. Boulder, CO 80301 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-10 |
| Decision Date | 2014-04-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521702882 | K140339 | 000 |