Cleared Traditional

K837344 - BEAM BLOCK SHAPER (FDA 510(k) Clearance)

May 1983
Decision
49d
Days
Risk

K837344 is an FDA 510(k) clearance for the BEAM BLOCK SHAPER..

Submitted by Mick Radio-Nuclear Instruments, Inc. (Bronx, US). The FDA issued a Cleared decision on May 9, 1983, 49 days after receiving the submission on March 21, 1983.

This device falls under the Radiology FDA review panel.

Submission Details

510(k) Number K837344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1983
Decision Date May 09, 1983
Days to Decision 49 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary

Device Classification

Product Code
Device Class