The following data is part of a premarket notification filed by Somanetics Corp. with the FDA for Oxyalert Nirsensors, Accessories For Invos 5100c System, Models: Is-c And Is-s.
| Device ID | K091224 |
| 510k Number | K091224 |
| Device Name: | OXYALERT NIRSENSORS, ACCESSORIES FOR INVOS 5100C SYSTEM, MODELS: IS-C AND IS-S |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-27 |
| Decision Date | 2009-07-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521211138 | K091224 | 000 |
| 10884521528062 | K091224 | 000 |
| 10884521185883 | K091224 | 000 |
| 10884521211186 | K091224 | 000 |
| 10884521185869 | K091224 | 000 |
| 10884521185876 | K091224 | 000 |
| 10884521185890 | K091224 | 000 |
| 10884521185906 | K091224 | 000 |
| 10884521185913 | K091224 | 000 |
| 20884521810379 | K091224 | 000 |
| 20884521810362 | K091224 | 000 |
| 10884521211117 | K091224 | 000 |
| 10884521211179 | K091224 | 000 |
| 10884521211193 | K091224 | 000 |
| 10884521552623 | K091224 | 000 |
| 10884521106086 | K091224 | 000 |
| 10884521106222 | K091224 | 000 |
| 20884521211121 | K091224 | 000 |
| 10884521528055 | K091224 | 000 |