Cleared Traditional

BIOPSY FIXATION UNIT-TYPE UA 0997

K875357 · Bruel & Kjaer Industri A/S · Radiology
Jul 1988
Decision
183d
Days
Class 2
Risk

About This 510(k) Submission

K875357 is an FDA 510(k) clearance for the BIOPSY FIXATION UNIT-TYPE UA 0997, 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 July 1, 1988, 183 days after receiving the submission on December 31, 1987. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1560.

Submission Details

510(k) Number K875357 FDA.gov
FDA Decision Cleared SESE
Date Received December 31, 1987
Decision Date July 01, 1988
Days to Decision 183 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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