Cleared Traditional

RITTERMODEL 75 EVOLUTION UNIV POW EXAM TABLE/ACCES

K926463 · Midmark Corp. · General & Plastic Surgery
Oct 1994
Decision
666d
Days
Class 1
Risk

About This 510(k) Submission

K926463 is an FDA 510(k) clearance for the RITTERMODEL 75 EVOLUTION UNIV POW EXAM TABLE/ACCES, a Table, Operating-room, Ac-powered (Class I — General Controls, product code FQO), submitted by Midmark Corp. (Versailles, US). The FDA issued a Cleared decision on October 21, 1994, 666 days after receiving the submission on December 24, 1992. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4960.

Submission Details

510(k) Number K926463 FDA.gov
FDA Decision Cleared SESE
Date Received December 24, 1992
Decision Date October 21, 1994
Days to Decision 666 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code FQO — Table, Operating-room, Ac-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4960