The following data is part of a premarket notification filed by Alertis Medical As with the FDA for Iscalert Sensor System.
| Device ID | K071165 |
| 510k Number | K071165 |
| Device Name: | ISCALERT SENSOR SYSTEM |
| Classification | Analyzer, Gas, Carbon-dioxide, Partial Pressure, Blood-phase, Indwelling |
| Applicant | ALERTIS MEDICAL AS 6470 RIVERVIEW TERRACE Fridley, MN 55432 |
| Contact | Constance G Bundy |
| Correspondent | Constance G Bundy ALERTIS MEDICAL AS 6470 RIVERVIEW TERRACE Fridley, MN 55432 |
| Product Code | CCC |
| CFR Regulation Number | 868.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-26 |
| Decision Date | 2007-11-07 |
| Summary: | summary |