Cleared Traditional

DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535, MODIFIED

K914945 · Bruel & Kjaer Industri A/S · Radiology
Jun 1992
Decision
235d
Days
Class 2
Risk

About This 510(k) Submission

K914945 is an FDA 510(k) clearance for the DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535, MODIFIED, a System, Imaging, Pulsed Echo, Ultrasonic (Class II — Special Controls, product code IYO), submitted by Bruel & Kjaer Industri A/S (Denmark, DK). The FDA issued a Cleared decision on June 26, 1992, 235 days after receiving the submission on November 4, 1991. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1560.

Submission Details

510(k) Number K914945 FDA.gov
FDA Decision Cleared SESE
Date Received November 04, 1991
Decision Date June 26, 1992
Days to Decision 235 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

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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