Cleared Traditional

ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION

K991805 · Acuson Corp. · Radiology
Aug 1999
Decision
68d
Days
Class 2
Risk

About This 510(k) Submission

K991805 is an FDA 510(k) clearance for the ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION, 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 August 2, 1999, 68 days after receiving the submission on May 26, 1999. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K991805 FDA.gov
FDA Decision Cleared SESE
Date Received May 26, 1999
Decision Date August 02, 1999
Days to Decision 68 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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