Cleared Traditional

K827503 - SONOLINE 1000, 8008 AND 8080 (FDA 510(k) Clearance)

Aug 1982
Decision
18d
Days
Risk

K827503 is an FDA 510(k) clearance for the SONOLINE 1000, 8008 AND 8080..

Submitted by Siemens Medical Solutions USA, Inc. (Issaquah, US). The FDA issued a Cleared decision on August 16, 1982, 18 days after receiving the submission on July 29, 1982.

This device falls under the Radiology FDA review panel.

Submission Details

510(k) Number K827503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1982
Decision Date August 16, 1982
Days to Decision 18 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary

Device Classification

Product Code
Device Class