The following data is part of a premarket notification filed by Somanetics Corp. with the FDA for Vital Sync Model 5000 Series.
| Device ID | K093422 |
| 510k Number | K093422 |
| Device Name: | VITAL SYNC MODEL 5000 SERIES |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | SOMANETICS CORP. 1653 EAST MAPLE RD. Troy, MI 48083 -4208 |
| Contact | Ronald A Widman |
| Correspondent | Ronald A Widman SOMANETICS CORP. 1653 EAST MAPLE RD. Troy, MI 48083 -4208 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-03 |
| Decision Date | 2010-04-29 |
| Summary: | summary |