FETAL ASSESSMENT CAP

System, Imaging, Pulsed Echo, Ultrasonic

ACUSON CORP.

The following data is part of a premarket notification filed by Acuson Corp. with the FDA for Fetal Assessment Cap.

Pre-market Notification Details

Device IDK992580
510k NumberK992580
Device Name:FETAL ASSESSMENT CAP
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant ACUSON CORP. 1220 CHARLESTON RD. Mountain View,  CA  94039 -7393
ContactWilliam E Welch
CorrespondentWilliam E Welch
ACUSON CORP. 1220 CHARLESTON RD. Mountain View,  CA  94039 -7393
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-08-02
Decision Date1999-10-18
Summary:summary

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