FDA.reportPublic FDA data

CSA Medical

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30101402653010140265CSA Medical1N2026-01-01131 Hartwell Ave Lexington MA US 02421

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1594841165902809K172041truFreeze SystemGEH2017-07-27
1594841350634208K171626truFreeze SystemGEH2017-08-30
1594841092953902K171522truFreeze Rapid AV Spray KitGEH2017-07-14
1594841999881272K163244truFreeze SystemGEH2017-05-24
1594841423254522K162695truFreeze SystemGEH2016-10-25
1594841756866236K161557truFreeze SystemGEH2016-07-26
1594841958579784K160273truFreeze SystemGEH2016-03-25
1594841077095171K152668truFreeze SystemGEH2015-10-14
1594841682218235K150920truFreeze SystemGEH2015-06-17
1594841669575809K143625truFreeze SystemGEH2015-01-15
1594841343352376K133258TRUFREEZE SYSTEMGEH2014-06-19
1594841678732028K113021TRUFREEZE SYSTEM, TRUFREEZE SPRAY KITGEH2012-02-07
1594841693033419
1594842063942200

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEH122017-08-30