The following data is part of a premarket notification filed by Marquette Electronics, Inc. with the FDA for Pds 9000 Patient Data Mgmt. System.
| Device ID | K855055 |
| 510k Number | K855055 |
| Device Name: | PDS 9000 PATIENT DATA MGMT. SYSTEM |
| Classification | Computer, Diagnostic, Programmable |
| 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 | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-18 |
| Decision Date | 1986-02-12 |