Cleared Traditional

STORZ COMPUSCAN AB

K930278 · Storz · Radiology
Feb 1994
Decision
384d
Days
Class 2
Risk

About This 510(k) Submission

K930278 is an FDA 510(k) clearance for the STORZ COMPUSCAN AB, a System, Imaging, Pulsed Echo, Ultrasonic (Class II — Special Controls, product code IYO), submitted by Storz (St. Louis, US). The FDA issued a Cleared decision on February 9, 1994, 384 days after receiving the submission on January 21, 1993. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1560.

Submission Details

510(k) Number K930278 FDA.gov
FDA Decision Cleared SESE
Date Received January 21, 1993
Decision Date February 09, 1994
Days to Decision 384 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IYO — System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1560

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