FDA.reportPublic FDA data

OPTAIN HEALTH

Matched from indexed company URL: Optain Health, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30387906353038790635OPTAIN HEALTH1N2026-01-01526 S Main St Ste 211 Akron OH US 44311

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3410351611191905K250683Resolve Fundus CameraHKI2025-04-30

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HKI12025-04-30

PMN#

GUDID#