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 | K082327 |
| 510k Number | K082327 |
| 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 | 2008-08-14 |
| Decision Date | 2009-04-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521211152 | K082327 | 000 |
| 10884521824416 | K082327 | 000 |
| 10884521145603 | K082327 | 000 |
| 10884521145610 | K082327 | 000 |
| 10884521145573 | K082327 | 000 |
| 10884521145580 | K082327 | 000 |
| 10884521145627 | K082327 | 000 |
| 10884521145597 | K082327 | 000 |
| 30884521211166 | K082327 | 000 |
| 10884521104228 | K082327 | 000 |
| 10884521105904 | K082327 | 000 |
| 10884521105911 | K082327 | 000 |
| 10884521105942 | K082327 | 000 |
| 10884521824409 | K082327 | 000 |