FDA.reportPublic FDA data

RESPIRE MEDICAL

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30089375613008937561RESPIRE MEDICAL1N2020-04-2518 Bridge St Suite 3J Brooklyn NY US 11201

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1258292050653021K192127Respire Pink AT (Hard, Hard/Soft, EF)LRK2020-02-05
1258291094257338K170692Respire Pink Series with DentiTracLRK2017-05-26
1258291377924855K152292Respire Blue Series-EFLRK2015-12-07
1258291905114732K150572Respire Pink Series-Herbst-EFLRK2015-08-27
1258292051668376K131138RESPIRE PINK SERIES - HERBSTLRK2013-09-09
1258291520451939K111207RESPIRE BLUE SERIESLRK2011-08-23
1258291079716210
1258292050653021

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LRK62020-02-05

PMN#