Cleared Traditional

S5192R TRANSDUCER

K904951 · Acuson Corp. · Radiology
Apr 1991
Decision
178d
Days
Class 2
Risk

About This 510(k) Submission

K904951 is an FDA 510(k) clearance for the S5192R 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 April 29, 1991, 178 days after receiving the submission on November 2, 1990. This device falls under the Radiology review panel. Regulated under 21 CFR 884.2660.

Submission Details

510(k) Number K904951 FDA.gov
FDA Decision Cleared SESE
Date Received November 02, 1990
Decision Date April 29, 1991
Days to Decision 178 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