Cleared Traditional

POWER EXAMINATION TABLE MODEL # 411

K894134 · Midmark Corp. · General Hospital
Aug 1989
Decision
76d
Days
Class 1
Risk

About This 510(k) Submission

K894134 is an FDA 510(k) clearance for the POWER EXAMINATION TABLE MODEL # 411, a Table, Examination, Medical, Powered (Class I — General Controls, product code LGX), submitted by Midmark Corp. (Versailles, US). The FDA issued a Cleared decision on August 28, 1989, 76 days after receiving the submission on June 13, 1989. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4960.

Submission Details

510(k) Number K894134 FDA.gov
FDA Decision Cleared SESE
Date Received June 13, 1989
Decision Date August 28, 1989
Days to Decision 76 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code LGX — Table, Examination, Medical, Powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4960