Cleared Traditional

L328 TRANSDUCER

K905456 · Acuson Corp. · Radiology
May 1991
Decision
175d
Days
Class 2
Risk

About This 510(k) Submission

K905456 is an FDA 510(k) clearance for the L328 TRANSDUCER, a Monitor, Fetal Doppler Ultrasound (Class II — Special Controls, product code MAA), submitted by Acuson Corp. (Mountain View, US). The FDA issued a Cleared decision on May 28, 1991, 175 days after receiving the submission on December 4, 1990. This device falls under the Radiology review panel. Regulated under 21 CFR 884.2660.

Submission Details

510(k) Number K905456 FDA.gov
FDA Decision Cleared SESE
Date Received December 04, 1990
Decision Date May 28, 1991
Days to Decision 175 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary —

Device Classification

Product Code MAA — Monitor, Fetal Doppler Ultrasound
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.2660