Cleared Traditional

VARIABLE CONTRAST ACUIOMETER, DIAGNOSTIC LASER INTERFEROMETER

K827577 · Randwal Instrument Co., Inc. · Radiology
Jan 1983
Decision
35d
Days
Risk

About This 510(k) Submission

K827577 is an FDA 510(k) clearance for the VARIABLE CONTRAST ACUIOMETER, DIAGNOSTIC LASER INTERFEROMETER, submitted by Randwal Instrument Co., Inc. (Southbridge, US). The FDA issued a Cleared decision on January 24, 1983, 35 days after receiving the submission on December 20, 1982. This device falls under the Radiology review panel.

Submission Details

510(k) Number K827577 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 1982
Decision Date January 24, 1983
Days to Decision 35 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary

Device Classification

Product Code
Device Class