The following data is part of a premarket notification filed by Marquette Electronics, Inc. with the FDA for Centra Ii Analysis System.
| Device ID | K922171 |
| 510k Number | K922171 |
| Device Name: | CENTRA II ANALYSIS SYSTEM |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | MARQUETTE ELECTRONICS, INC. 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Contact | Kristin Pabst |
| Correspondent | Kristin Pabst MARQUETTE ELECTRONICS, INC. 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-08 |
| Decision Date | 1992-12-28 |