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PROSOMNUS SLEEP TECHNOLOGIES

Matched from indexed company URL: Prosomnus Sleep Technologies

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30131166773013116677PROSOMNUS SLEEP TECHNOLOGIES1N2026-01-015675 Gibraltar Drive Pleasanton CA US 94588

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2021921509213567K252765ProSomnus RPMO2 OSA Device (RPMO2 OSA)PLC2026-04-06
2021921012077790K221889ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient MonitoringLRK2022-10-06
2021921298258755K202529ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient MonitoringLRK2020-11-20
2021921391260875K172859Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorderPLC2017-11-22
2021922072915965K161624MicrO2 OSA Device with Micro-RecorderPLC2016-11-07
2021921127622701K133683MICR02 OSA DEVICELRK2014-07-24
2021921467770445

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PLC32026-04-06
LRK32022-10-06

PMN#

GUDID#