FDA.reportPublic FDA data

SOMNETICS INTERNATIONAL, INC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30087701043008770104SOMNETICS INTERNATIONAL, INC1N2026-01-01103 Osborne Road NE Fridley MN US 55432

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1283381277072032K252338MySleepDashBZD2026-04-17
1283381138218662K180388Transcend 365 miniCPAP SystemBZD2018-11-30
1283381117957577K132127TRANSCEND AUTOBZD2013-10-17
1283381714372580K131388TRANSCEND HEATED HUMIDIFIERBTT2013-09-26
1283382048268423K100121MODEL 300157 CPAP SYSTEMBZD2010-07-13
1283381119223563
1283381506939167

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
BZD42026-04-17
BTT12013-09-26