The following data is part of a premarket notification filed by Marquette Electronics, Inc. with the FDA for Series 7000 End Tidal Co2 Monitoring System.
| Device ID | K851001 |
| 510k Number | K851001 |
| Device Name: | SERIES 7000 END TIDAL CO2 MONITORING SYSTEM |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | MARQUETTE ELECTRONICS, INC. 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Contact | Thomas Massopust |
| Correspondent | Thomas Massopust 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 | 1985-03-12 |
| Decision Date | 1985-05-13 |