VUPAD

System, Imaging, Pulsed Echo, Ultrasonic

SONOMED, INC.

The following data is part of a premarket notification filed by Sonomed, Inc. with the FDA for Vupad.

Pre-market Notification Details

Device IDK140199
510k NumberK140199
Device Name:VUPAD
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant SONOMED, INC. 1979 MARCUS AVE., SUITE 105C Lake Success,  NY  11042
ContactCharles C O'neal
CorrespondentCharles C O'neal
SONOMED, INC. 1979 MARCUS AVE., SUITE 105C Lake Success,  NY  11042
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-01-27
Decision Date2014-04-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00896100002170 K140199 000
00896100002026 K140199 000
00896100002033 K140199 000
00896100002040 K140199 000
00896100002057 K140199 000
00896100002064 K140199 000
00896100002125 K140199 000
00896100002132 K140199 000
00896100002149 K140199 000
00896100002156 K140199 000
00896100002163 K140199 000
00896100002019 K140199 000

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