FDA.reportPublic FDA data

CIRCADIANCE

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30061826323006182632CIRCADIANCE1N2026-01-011010 Corporate Lane Export PA US 15632

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
978831314460622K162905SleepWeaver 3D Nasal MaskBZD2017-03-15
978831359874158K151683SleepWeaver Advance Pediatric Nasal CPAP MaskBZD2016-04-05
978831318147365K130481SLEEPWEAVER ANEW FULL FACE SOFT CLOTH PAP MASKBZD2013-05-24
978831851431366K120757SLEEPWEAVER ELAN NASAL CPAP MASKBZD2012-04-24
978832070232296K103410NEOPAP SYSTEMBZD2011-03-30
978831023616217K092362SLEEPWEAVER NASAL CPAP MASKBZD2009-11-02
978831041677162K092362SLEEPWEAVER NASAL CPAP MASKBZD2009-11-02
978831411902754K061256SMARTMONITOR 2PSNPF2006-08-02
978831300285944K032403SMARTMONITOR 2 PROFESSIONAL SERIES (PS)NPF2003-10-27
978831799264044K011597SMARTMONITOR 2, MODEL 4000FLS2002-01-11
978831906113440

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
BZD142017-03-15
NPF42006-08-02
FLS22002-01-11