ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION

System, Imaging, Pulsed Doppler, Ultrasonic

ACUSON CORP.

The following data is part of a premarket notification filed by Acuson Corp. with the FDA for Aspen Ultrasound With Freestyle Imaging Option.

Pre-market Notification Details

Device IDK991805
510k NumberK991805
Device Name:ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant ACUSON CORP. 1220 CHARLESTON RD. Mountain View,  CA  94039 -7393
ContactWilliam Welch
CorrespondentWilliam Welch
ACUSON CORP. 1220 CHARLESTON RD. Mountain View,  CA  94039 -7393
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-05-26
Decision Date1999-08-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04056869005218 K991805 000
04056869005188 K991805 000
04056869005058 K991805 000
04056869005041 K991805 000
04056869005034 K991805 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.