Cleared Traditional

K827929 - MOBILETT, MOBILE X-RAY UNIT (FDA 510(k) Clearance)

Sep 1982
Decision
27d
Days
Risk

K827929 is an FDA 510(k) clearance for the MOBILETT, MOBILE X-RAY UNIT..

Submitted by Siemens Medical Solutions USA, Inc. (Issaquah, US). The FDA issued a Cleared decision on September 13, 1982, 27 days after receiving the submission on August 17, 1982.

This device falls under the Radiology FDA review panel.

Submission Details

510(k) Number K827929 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1982
Decision Date September 13, 1982
Days to Decision 27 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary

Device Classification

Product Code
Device Class