Cleared Traditional

K930230 - RADIOGRAPHIC WALL-MOUNTED CASSETTE HOLDER
(FDA 510(k) Clearance)

Apr 1993
Decision
98d
Days
Class 1
Risk

K930230 is an FDA 510(k) clearance for the RADIOGRAPHIC WALL-MOUNTED CASSETTE HOLDER. This device is classified as a Holder, Radiographic Cassette, Wall-mounted (Class I - General Controls, product code IXY).

Submitted by American Medical Sales, Inc. (Culver City, US). The FDA issued a Cleared decision on April 27, 1993, 98 days after receiving the submission on January 19, 1993.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1880.

Submission Details

510(k) Number K930230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1993
Decision Date April 27, 1993
Days to Decision 98 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code IXY — Holder, Radiographic Cassette, Wall-mounted
Device Class Class I - General Controls
CFR Regulation 21 CFR 892.1880

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