The following data is part of a premarket notification filed by Siemens Medical Laboratories, Inc. with the FDA for Patient Data Management System (project 735).
| Device ID | K894230 |
| 510k Number | K894230 |
| Device Name: | PATIENT DATA MANAGEMENT SYSTEM (PROJECT 735) |
| Classification | Accelerator, Linear, Medical |
| Applicant | SIEMENS MEDICAL LABORATORIES, INC. 2404 N. MAIN ST. Walnut Creek, CA 94596 |
| Contact | Morton Jr. |
| Correspondent | Morton Jr. SIEMENS MEDICAL LABORATORIES, INC. 2404 N. MAIN ST. Walnut Creek, CA 94596 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-19 |
| Decision Date | 1989-08-28 |