The following data is part of a premarket notification filed by Marquette Electronics, Inc. with the FDA for Smart Anesthesia Multi-gas (sam) Module.
| Device ID | K950581 |
| 510k Number | K950581 |
| Device Name: | SMART ANESTHESIA MULTI-GAS (SAM) MODULE |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | MARQUETTE ELECTRONICS, INC. 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Contact | Dianne Schmitz |
| Correspondent | Dianne Schmitz MARQUETTE ELECTRONICS, INC. 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-09 |
| Decision Date | 1995-03-29 |