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 | K160718 |
| 510k Number | K160718 |
| Device Name: | Vital Sync Informatics Manager & Virtual Patient Monitoring Platform |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | COVIDIEN 6135 Gunbarrel Avenue Boulder, CO 80301 |
| Contact | Timothy Holwick |
| Correspondent | Timothy Holwick COVIDIEN 6135 Gunbarrel Avenue Boulder, CO 80301 |
| Product Code | MWI |
| Subsequent Product Code | DXJ |
| Subsequent Product Code | OUG |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-15 |
| Decision Date | 2016-11-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521795273 | K160718 | 000 |
| 10884521795143 | K160718 | 000 |
| 10884521829855 | K160718 | 000 |
| 10884521835962 | K160718 | 000 |
| 10884521835870 | K160718 | 000 |
| 10884521844933 | K160718 | 000 |
| 10884521845176 | K160718 | 000 |
| 10884521844940 | K160718 | 000 |
| 10884521847675 | K160718 | 000 |
| 10884521849358 | K160718 | 000 |
| 10884521795150 | K160718 | 000 |
| 10884521762619 | K160718 | 000 |
| 10884521780668 | K160718 | 000 |
| 10884521812208 | K160718 | 000 |
| 10884521809246 | K160718 | 000 |
| 10884521810334 | K160718 | 000 |
| 10884521815810 | K160718 | 000 |
| 10884521757127 | K160718 | 000 |
| 10884521818965 | K160718 | 000 |
| 10884521823372 | K160718 | 000 |
| 10884521829848 | K160718 | 000 |
| 10884521806740 | K160718 | 000 |
| 10884521847569 | K160718 | 000 |