Cleared Traditional

ORTHOCEPH OC100

K930338 · Instrumentarium Corp. · Radiology
Apr 1993
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K930338 is an FDA 510(k) clearance for the ORTHOCEPH OC100, a Unit, X-ray, Extraoral With Timer (Class II — Special Controls, product code EHD), submitted by Instrumentarium Corp. (Tuusula, FI). The FDA issued a Cleared decision on April 27, 1993, 92 days after receiving the submission on January 25, 1993. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number K930338 FDA.gov
FDA Decision Cleared SESE
Date Received January 25, 1993
Decision Date April 27, 1993
Days to Decision 92 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code EHD — Unit, X-ray, Extraoral With Timer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.1800

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