The following data is part of a premarket notification filed by Somanetics Corp. with the FDA for Invos Cerebral/somatic Oximeter System, Model 5100c.
| Device ID | K080769 |
| 510k Number | K080769 |
| Device Name: | INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL 5100C |
| Classification | Oximeter, Tissue Saturation |
| 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 | MUD |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-18 |
| Decision Date | 2008-05-14 |
| Summary: | summary |