Cleared Special

K021497 - CYPRESS ULTRASOUND SYSTEM
(FDA 510(k) Clearance)

K021497 · Acuson Corp. · Radiology
Jul 2002
Decision
61d
Days
Class 2
Risk

K021497 is an FDA 510(k) clearance for the CYPRESS ULTRASOUND SYSTEM, 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 July 9, 2002, 61 days after receiving the submission on May 9, 2002. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K021497 FDA.gov
FDA Decision Cleared SESE
Date Received May 09, 2002
Decision Date July 09, 2002
Days to Decision 61 days
Submission Type Special
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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