Cleared Traditional

K827815 - SONOLINE 6000 (FDA 510(k) Clearance)

Aug 1982
Decision
27d
Days
Risk

K827815 is an FDA 510(k) clearance for the SONOLINE 6000..

Submitted by Siemens Medical Solutions USA, Inc. (Issaquah, US). The FDA issued a Cleared decision on August 24, 1982, 27 days after receiving the submission on July 28, 1982.

This device falls under the Radiology FDA review panel.

Submission Details

510(k) Number K827815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1982
Decision Date August 24, 1982
Days to Decision 27 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary

Device Classification

Product Code
Device Class