The following data is part of a premarket notification filed by Somanetics Corp. with the FDA for Somanetics Invos 3100a Cerebral Oximeter (invos).
| Device ID | K971628 |
| 510k Number | K971628 |
| Device Name: | SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS) |
| Classification | Oximeter |
| 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 | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-02 |
| Decision Date | 1997-10-10 |
| Summary: | summary |