The following data is part of a premarket notification filed by Marquette Electronics, Inc. with the FDA for Marquette Sv O2 Module.
| Device ID | K915073 |
| 510k Number | K915073 |
| Device Name: | MARQUETTE SV O2 MODULE |
| Classification | Catheter, Oximeter, Fiber-optic |
| Applicant | MARQUETTE ELECTRONICS, INC. 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Contact | Gerry Buss |
| Correspondent | Gerry Buss MARQUETTE ELECTRONICS, INC. 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Product Code | DQE |
| CFR Regulation Number | 870.1230 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-08 |
| Decision Date | 1992-12-29 |