Cleared Traditional

K864501 - KOKEN'S NEW MODEL M-3000 POWER TABLE (FDA 510(k) Clearance)

Dec 1986
Decision
32d
Days
Risk

K864501 is an FDA 510(k) clearance for the KOKEN'S NEW MODEL M-3000 POWER TABLE..

Submitted by Koken Mfg Company, Inc. (St. Louis, US). The FDA issued a Cleared decision on December 16, 1986, 32 days after receiving the submission on November 14, 1986.

This device falls under the Physical Medicine FDA review panel.

Submission Details

510(k) Number K864501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1986
Decision Date December 16, 1986
Days to Decision 32 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary

Device Classification

Product Code
Device Class