Cleared Traditional

K862593 - DAS 211 (FDA 510(k) Clearance)

Sep 1986
Decision
62d
Days
Risk

K862593 is an FDA 510(k) clearance for the DAS 211..

Submitted by Philips Medical Systems (Cleveland), Inc. (Highland Heights, US). The FDA issued a Cleared decision on September 8, 1986, 62 days after receiving the submission on July 8, 1986.

This device falls under the Radiology FDA review panel.

Submission Details

510(k) Number K862593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1986
Decision Date September 08, 1986
Days to Decision 62 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary

Device Classification

Product Code
Device Class