FDA.reportPublic FDA data

Auris Health, Inc

Matched from indexed company URL: Auris Health Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30174259753014447948Auris Health, Inc1N2026-01-015490 Great America Pkwy Santa Clara CA US 95054
30234607643023460764Auris Health, Inc.1N2026-01-01170 Baytech Drive San Jose CA US 95134
30089754243008975424AURIS HEALTH, INC.1N2020-04-252383 Bering Dr San Jose CA US 95131
30144479483014447948AURIS HEALTH, INC.1N2020-04-25150 Shoreline Drive Redwood City CA US 94065

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3079971836754522K243219MONARCH™ Platform (MON-000008)EOQ2025-01-23
3002261836754522K243219MONARCH™ Platform (MON-000008)EOQ2025-01-23
3079971434563665K231473Monarch BronchoscopeQNW2023-11-28
3002261434563665K231473Monarch BronchoscopeQNW2023-11-28
3079971722187029K213334Monarch Platform, UrologyFGB2022-04-29
3002261722187029K213334Monarch Platform, UrologyFGB2022-04-29
3002261053666072K211493Monarch PlatformEOQ2021-07-09
3079971053666072K211493Monarch PlatformEOQ2021-07-09
3079971924559901K203614Monarch BronchoscopeQNW2021-03-11
3002261924559901K203614Monarch BronchoscopeQNW2021-03-11
3079971017810595K193534Monarch PlatformEOQ2020-04-15
3002261017810595K193534Monarch PlatformEOQ2020-04-15
3079971263618012K173760Monarch Endoscopy Platform (Monarch Platform)EOQ2018-03-22
3002261263618012K173760Monarch Endoscopy Platform (Monarch Platform)EOQ2018-03-22
2180101263618012K173760Monarch Endoscopy Platform (Monarch Platform)EOQ2018-03-22
2179041263618012K173760Monarch Endoscopy Platform (Monarch Platform)EOQ2018-03-22
3002261223725904
3079971223725904
3002261793892324
3079971793892324
3002261932989262
3079971932989262

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EOQ102025-01-23
QNW42023-11-28
FGB22022-04-29

PMN#

GUDID#

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