Cleared Traditional

K827993 - MTH C/A MOBILE C ARM
(FDA 510(k) Clearance)

Sep 1982
Decision
20d
Days
Risk

K827993 is an FDA 510(k) clearance for the MTH C/A MOBILE C ARM..

Submitted by General Medical Merate S.P.A (Seriate, Bergamo, IT). The FDA issued a Cleared decision on September 13, 1982, 20 days after receiving the submission on August 24, 1982.

This device falls under the Radiology FDA review panel.

Submission Details

510(k) Number K827993 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1982
Decision Date September 13, 1982
Days to Decision 20 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary

Device Classification

Product Code
Device Class