Cleared Traditional

AMENDMENT ULTRASOUND SCANNER TYPE 1842/1846/1849

K852502 · Bruel & Kjaer Industri A/S · Radiology
Oct 1986
Decision
498d
Days
Class 2
Risk

About This 510(k) Submission

K852502 is an FDA 510(k) clearance for the AMENDMENT ULTRASOUND SCANNER TYPE 1842/1846/1849, 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 October 23, 1986, 498 days after receiving the submission on June 12, 1985. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1560.

Submission Details

510(k) Number K852502 FDA.gov
FDA Decision Cleared SESE
Date Received June 12, 1985
Decision Date October 23, 1986
Days to Decision 498 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary —

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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