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OTU Medical Inc

Matched from indexed company URL: OTU Medical Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30139929773013992977OTU Medical Inc1N2026-01-012847A Whipple Rd. Union City CA US 94587

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2235311871915138K231702WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical TabletFAJ2023-09-29
2235312062442179K220399WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image SystemEOQ2022-06-16
2235311902436714K212202WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image SystemFAJ2022-04-13
2235311146480654K210579WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image SystemFGB2021-07-22
2235311095549457K181977WiScope Digital Endoscope SystemFGB2018-08-14

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FAJ22023-09-29
FGB22021-07-22
EOQ12022-06-16

PMN#

GUDID#

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