Auris Health Inc

FDA Filings

This page includes the latest FDA filings for Auris Health Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3008975424
FEI Number3008975424
NameAURIS HEALTH, INC.
Owner & OperatorAuris Health, Inc.
Contact Address150 Shoreline Drive
Redwood City CA 94065 US
Official Correspondent
  • Joy Sacmar
  • 1-650-6100750-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2383 Bering Dr
San Jose, CA 95131 US
Establishment TypeManufacture Medical Device



Registration Number3014447948
FEI Number3014447948
NameAURIS HEALTH, INC.
Owner & OperatorAuris Health, Inc.
Contact Address150 Shoreline Drive
Redwood City CA 94065 US
Official Correspondent
  • Joy Sacmar
  • 1-650-6100750-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address150 Shoreline Drive
Redwood City, CA 94065 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
AURIS HEALTH, INC.
Monarch Advanced Imaging Accessory Kit MON-0007092021-07-23
Auris Health, Inc.
Monarch Platform2021-07-09
AURIS HEALTH, INC.
Monarch Bronchoscope MBR-000211-B2021-05-21
AURIS HEALTH, INC.
Monarch Bronchoscope MRB-000211-A2021-05-13
AURIS HEALTH, INC.
Monarch Bronchoscope MBR-000211-A2021-03-25
AURIS HEALTH, INC.
Monarch Endoscopy Platform (P1) Tower Upgrade 2020-07-21
AURIS HEALTH, INC.
Monarch Bronchscope 2.0/Monarch Platform (P2) 2020-07-10
AURIS HEALTH, INC.
Monarch Endoscopy Platform (P1) Tower Upgrade 2020-07-10
Auris Health, Inc.
Monarch Platform2020-04-15
AURIS HEALTH, INC.
Monarch Software Laptop v2.2.1 2020-03-13
AURIS HEALTH, INC.
Monarch Software Cart v2.2.1 2020-03-13
AURIS HEALTH, INC.
Monarch Software Tower v2.2.1 2020-03-13
AURIS HEALTH, INC.
Monarch Software Laptop v2.1.6 2020-03-13
AURIS HEALTH, INC.
Monarch Software Cart v2.1.6 2020-03-13
AURIS HEALTH, INC.
Monarch Software Tower v2.1.6 2020-03-13
AURIS HEALTH, INC.
Navigation Patient Patches MBR-0000162019-10-23
AURIS HEALTH, INC.
Monarch™ Software Laptop v2.1.5 2019-09-18
AURIS HEALTH, INC.
Monarch™ Software Cart v2.1.5 2019-09-18
AURIS HEALTH, INC.
Monarch™ Software Tower v2.1.5 2019-09-18
AURIS HEALTH, INC.
Monarch™ Software Laptop v2.1.4 2019-05-20
AURIS HEALTH, INC.
Monarch™ Software Cart v2.1.4 2019-05-20
AURIS HEALTH, INC.
Monarch™ Software Tower v2.1.4 2019-05-20
AURIS HEALTH, INC.
Monarch™ Platform (Refurbished) MON000005R2019-05-20
AURIS HEALTH, INC.
Bronchoscope Fluidics Tubing MBR-0000182019-04-23
AURIS HEALTH, INC.
Monarch™ Software Laptop v2.1.3 2018-11-15
AURIS HEALTH, INC.
Monarch™ Software Cart v2.1.3 2018-11-15
AURIS HEALTH, INC.
Monarch™ Software Tower v2.1.3 2018-11-15
AURIS HEALTH, INC.
Monarch™ Software Laptop v2.1.2 2018-07-09
AURIS HEALTH, INC.
Monarch™ Software Cart v2.1.2 2018-07-09
AURIS HEALTH, INC.
Monarch™ Software Tower v2.1.2 2018-07-09
AURIS HEALTH, INC.
Monarch™ Platform MON0000052018-07-09
AURIS HEALTH, INC.
Bronchoscope Sheath Valve MBR-0000202018-07-09
AURIS HEALTH, INC.
Bronchoscope Valve MBR-0000192018-07-09
AURIS HEALTH, INC.
Bronchoscope Patient Introducer Kit MBR-0000172018-07-09
AURIS HEALTH, INC.
Cytology Brush MBR-0000152018-07-09
AURIS HEALTH, INC.
Biopsy Forceps - Smooth Cup MBR-0000142018-07-09
AURIS HEALTH, INC.
Aspirating Biopsy Needle MBR-0000122018-07-09
AURIS HEALTH, INC.
Monarch™ Bronchoscope System MBR-0000112018-07-09
AURIS HEALTH, INC.
Monarch Platform2018-04-09
AURIS HEALTH, INC.
Monarch Platform2018-04-09
AURIS HEALTH, INC.
Monarch Platform2018-04-09
AURIS HEALTH, INC.
Monarch Platform2018-04-09

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