The following data is part of a premarket notification filed by Covidien, Formerly Nellcor Puritan Bennett, Inc. with the FDA for Vital Sync System.
| Device ID | K123002 |
| 510k Number | K123002 |
| Device Name: | VITAL SYNC SYSTEM |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT, INC. 6135 Gunbarrel Ave Boulder, CO 80301 |
| Contact | Kelsey Lee |
| Correspondent | Kelsey Lee COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT, INC. 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 | 2012-09-27 |
| Decision Date | 2013-02-27 |
| Summary: | summary |