Cleared Traditional

K827064 - SIEMENS POLYDOROS 800 (FDA 510(k) Clearance)

Feb 1982
Decision
40d
Days
Risk

K827064 is an FDA 510(k) clearance for the SIEMENS POLYDOROS 800..

Submitted by Siemens Medical Solutions USA, Inc. (Issaquah, US). The FDA issued a Cleared decision on February 24, 1982, 40 days after receiving the submission on January 15, 1982.

This device falls under the Radiology FDA review panel.

Submission Details

510(k) Number K827064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 1982
Decision Date February 24, 1982
Days to Decision 40 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary

Device Classification

Product Code
Device Class