Cleared Traditional

BETASTAR 1131.02 MOBILE OPERATING TABLE

K926525 · Stierlen-Maquet AG · General & Plastic Surgery
Oct 1993
Decision
286d
Days
Class 1
Risk

About This 510(k) Submission

K926525 is an FDA 510(k) clearance for the BETASTAR 1131.02 MOBILE OPERATING TABLE, a Table, Operating-room, Ac-powered (Class I — General Controls, product code FQO), submitted by Stierlen-Maquet AG (West-Germany, DE). The FDA issued a Cleared decision on October 12, 1993, 286 days after receiving the submission on December 30, 1992. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4960.

Submission Details

510(k) Number K926525 FDA.gov
FDA Decision Cleared SESE
Date Received December 30, 1992
Decision Date October 12, 1993
Days to Decision 286 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

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