Cleared Traditional

K827065 - SIEMENS SIRESKOP 4 (FDA 510(k) Clearance)

Feb 1982
Decision
34d
Days
Risk

K827065 is an FDA 510(k) clearance for the SIEMENS SIRESKOP 4..

Submitted by Siemens Medical Solutions USA, Inc. (Issaquah, US). The FDA issued a Cleared decision on February 18, 1982, 34 days after receiving the submission on January 15, 1982.

This device falls under the Radiology FDA review panel.

Submission Details

510(k) Number K827065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 1982
Decision Date February 18, 1982
Days to Decision 34 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary

Device Classification

Product Code
Device Class