Cleared Traditional

K828564 - COMPUTER DATA MONITORING SYSTEM (FDA 510(k) Clearance)

Jan 1983
Decision
87d
Days
Risk

K828564 is an FDA 510(k) clearance for the COMPUTER DATA MONITORING SYSTEM..

Submitted by Siemens Medical Solutions USA, Inc. (Issaquah, US). The FDA issued a Cleared decision on January 3, 1983, 87 days after receiving the submission on October 8, 1982.

This device falls under the Radiology FDA review panel.

Submission Details

510(k) Number K828564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1982
Decision Date January 03, 1983
Days to Decision 87 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary

Device Classification

Product Code
Device Class