Cleared Traditional

ACUSON MODEL 2001

K934915 · Acuson Corp. · Radiology
Oct 1994
Decision
371d
Days
Class 2
Risk

About This 510(k) Submission

K934915 is an FDA 510(k) clearance for the ACUSON MODEL 2001, a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by Acuson Corp. (Mountain View, US). The FDA issued a Cleared decision on October 21, 1994, 371 days after receiving the submission on October 15, 1993. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K934915 FDA.gov
FDA Decision Cleared SESE
Date Received October 15, 1993
Decision Date October 21, 1994
Days to Decision 371 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IYN — System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1550

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