AQUILEX FLUID CONTROL SYSTEM H112

Insufflator, Hysteroscopic

W.O.M. WORLD OF MEDICINE AG

The following data is part of a premarket notification filed by W.o.m. World Of Medicine Ag with the FDA for Aquilex Fluid Control System H112.

Pre-market Notification Details

Device IDK112642
510k NumberK112642
Device Name:AQUILEX FLUID CONTROL SYSTEM H112
ClassificationInsufflator, Hysteroscopic
Applicant W.O.M. WORLD OF MEDICINE AG 1480 CAMBRIDGE STREET Cambridge,  MA  02139
ContactSusanne Raab
CorrespondentSusanne Raab
W.O.M. WORLD OF MEDICINE AG 1480 CAMBRIDGE STREET Cambridge,  MA  02139
Product CodeHIG  
CFR Regulation Number884.1700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-09-12
Decision Date2012-02-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04056702002244 K112642 000
04056702002190 K112642 000
04056702002152 K112642 000
04056702002145 K112642 000
04056702002121 K112642 000

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