Cleared Traditional

ORTHOCEPH OC100 D

K001439 · Instrumentarium Corp. · Radiology
Jun 2000
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K001439 is an FDA 510(k) clearance for the ORTHOCEPH OC100 D, a System, X-ray, Extraoral Source, Digital (Class II — Special Controls, product code MUH), submitted by Instrumentarium Corp. (Milwaukee, US). The FDA issued a Cleared decision on June 22, 2000, 45 days after receiving the submission on May 8, 2000. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number K001439 FDA.gov
FDA Decision Cleared SESE
Date Received May 08, 2000
Decision Date June 22, 2000
Days to Decision 45 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code MUH — System, X-ray, Extraoral Source, Digital
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.1800

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