Cleared Traditional

OCTOPAQUE UNIVERSAL

K942916 · Octostop, Inc. · Radiology
Sep 1994
Decision
79d
Days
Class 2
Risk

About This 510(k) Submission

K942916 is an FDA 510(k) clearance for the OCTOPAQUE UNIVERSAL, a Table, Radiographic, Stationary Top (Class II — Special Controls, product code IXQ), submitted by Octostop, Inc. (Montreal, Qc., CA). The FDA issued a Cleared decision on September 8, 1994, 79 days after receiving the submission on June 21, 1994. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1980.

Submission Details

510(k) Number K942916 FDA.gov
FDA Decision Cleared SESE
Date Received June 21, 1994
Decision Date September 08, 1994
Days to Decision 79 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code IXQ — Table, Radiographic, Stationary Top
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1980

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