Cleared Traditional

K827455 - SONOLINE 3000 (FDA 510(k) Clearance)

Jul 1982
Decision
20d
Days
Risk

K827455 is an FDA 510(k) clearance for the SONOLINE 3000..

Submitted by Siemens Medical Solutions USA, Inc. (Issaquah, US). The FDA issued a Cleared decision on July 7, 1982, 20 days after receiving the submission on June 17, 1982.

This device falls under the Radiology FDA review panel.

Submission Details

510(k) Number K827455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1982
Decision Date July 07, 1982
Days to Decision 20 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary

Device Classification

Product Code
Device Class