ACUSON MODEL 2001

System, Imaging, Pulsed Doppler, Ultrasonic

ACUSON CORP.

The following data is part of a premarket notification filed by Acuson Corp. with the FDA for Acuson Model 2001.

Pre-market Notification Details

Device IDK934915
510k NumberK934915
Device Name:ACUSON MODEL 2001
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant ACUSON CORP. 1220 CHARLESTON RD. Mountain View,  CA  94039 -7393
ContactStephen T Johnson
CorrespondentStephen T Johnson
ACUSON CORP. 1220 CHARLESTON RD. Mountain View,  CA  94039 -7393
Product CodeIYN  
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-10-15
Decision Date1994-10-21

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