AURIS HEALTH, INC.

Address:150 Shoreline Drive,Redwood City,CA,94065,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Bronchoscope (Flexible Or Rigid) (EOQ) (10) System, X-Ray, Tomography, Computed (JAK) (8)

Premarket Exempt

Clear

Monarch™ Software Tower v2.1.2 - B634SW0032740201020 Catalog Number :

Device Description : Monarch™ Software Tower v2.1.2

Device Class : 2

Duns Number: 015823456

Premarket Exempt : No

Product Code : JAK, EOQ

Prescription Use : Yes

Device Count : 1

Monarch™ Software Tower v2.1.3 - B634SW0032740201030 Catalog Number :

Device Description : Monarch™ Software Tower v2.1.3

Device Class : 2

Duns Number: 015823456

Premarket Exempt : No

Product Code : EOQ, JAK

Prescription Use : Yes

Device Count : 1

Monarch™ Software Tower v2.1.4 - B634SW0032740201040 Catalog Number :

Device Description : Monarch™ Software Tower v2.1.4

Device Class : 2

Duns Number: 015823456

Premarket Exempt : No

Product Code : JAK, EOQ

Prescription Use : Yes

Device Count : 1

Monarch™ Software Tower v2.1.5 - B634SW0032740201050 Catalog Number :

Device Description : Monarch™ Software Tower v2.1.5

Device Class : 2

Duns Number: 015823456

Premarket Exempt : No

Product Code : EOQ, JAK

Prescription Use : Yes

Device Count : 1

Monarch™ Software Cart v2.1.2 - B634SW0032750201020 Catalog Number :

Device Description : Monarch™ Software Cart v2.1.2

Device Class : 2

Duns Number: 015823456

Premarket Exempt : No

Product Code : EOQ

Prescription Use : Yes

Device Count : 1

Monarch™ Software Cart v2.1.3 - B634SW0032750201030 Catalog Number :

Device Description : Monarch™ Software Cart v2.1.3

Device Class : 2

Duns Number: 015823456

Premarket Exempt : No

Product Code : EOQ, JAK

Prescription Use : Yes

Device Count : 1

Monarch™ Software Cart v2.1.4 - B634SW0032750201040 Catalog Number :

Device Description : Monarch™ Software Cart v2.1.4

Device Class : 2

Duns Number: 015823456

Premarket Exempt : No

Product Code : JAK, EOQ

Prescription Use : Yes

Device Count : 1

Monarch™ Software Cart v2.1.5 - B634SW0032750201050 Catalog Number :

Device Description : Monarch™ Software Cart v2.1.5

Device Class : 2

Duns Number: 015823456

Premarket Exempt : No

Product Code : EOQ, JAK

Prescription Use : Yes

Device Count : 1

Monarch™ Software Laptop v2.1.2 - B634SW0032760201020 Catalog Number :

Device Description : Monarch™ Software Laptop v2.1.2

Device Class : 2

Duns Number: 015823456

Premarket Exempt : No

Product Code : EOQ

Prescription Use : Yes

Device Count : 1

Monarch™ Software Laptop v2.1.3 - B634SW0032760201030 Catalog Number :

Device Description : Monarch™ Software Laptop v2.1.3

Device Class : 2

Duns Number: 015823456

Premarket Exempt : No

Product Code : EOQ, JAK

Prescription Use : Yes

Device Count : 1

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