Patient Data Management System (Project 735)
FDA 510(k) K894230 · Siemens Medical Laboratories, Inc.
510(k) numberK894230
Submission
- Device name
- Patient Data Management System (Project 735)
- Applicant
- Siemens Medical Laboratories, Inc.
Walnut Creek, CA, US - Received
- June 19, 1989
- Decision date
- August 28, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Patient Data Management System (Project 735) cleared by the FDA?
Patient Data Management System (Project 735) (K894230) received a 510(k) decision of Substantially Equivalent on August 28, 1989, 70 days after the submission was received.
What is the product code of K894230?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.