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

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00851861007208Respire Pink Series Micro H/S with DentiTrac - Intraoral appliance for the treatment of snoring and mild to moderate obstructive sleep apnea with patient monitoring.7186437326info@respiremedical.com
00851861007215Respire Pink Series EF Micro with DentiTrac - Intraoral appliance for the treatment of snoring and mild to moderate obstructive sleep apnea with patient monitoring.7186437326info@respiremedical.com
00851861007222Respire Pink+ Hard with DentiTrac - Intraoral appliance for the treatment of snoring and mild to moderate obstructive sleep apnea with patient monitoring.7187437326info@respiremedical.com
00851861007239Respire Pink+ H/S with DentiTrac - Intraoral appliance for the treatment of snoring and mild to moderate obstructive sleep apnea with patient monitoring.7186437326info@respiremedical.com
00851861007246Respire Pink EF+ with DentiTrac - Intraoral appliance for the treatment of snoring and mild to moderate obstructive sleep apnea with patient monitoring.7186437326info@respiremedical.com
00851861007253Respire Pink AT EF - Intraoral appliance indicated to treat mild to moderate Obstructive Sleep Apnea (OSA) in patients, 18 years of age or older.718-643-7326info@respiremedical.com
00851861007260Respire Pink AT Hard - Intraoral appliance indicated to treat mild to moderate Obstructive Sleep Apnea (OSA) in patients, 18 years of age or older.718-643-7326info@respiremedical.com

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#

GUDID#