Event Medical, Ltd.

Address:60 Empire Dr,Lake Forest,CA,92630,US

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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

Ventilator, Continuous, Facility Use (CBK) (6)

Premarket Exempt

Clear

eVolution 3e Ventilator - 00860008873606 Catalog Number : EVL100500-T, EVL100500-T-NF

Device Description : eVolution 3e Ventilator System

Device Class : 2

Duns Number: 791890861

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

INSPIRATION 7i Ventilator - 00860008873637 Catalog Number : F7300000-7i-F, F7300000-7i-L

Device Description : INSPIRATION 7i Ventilator System, 17" screen

Device Class : 2

Duns Number: 791890861

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

EVOLUTION - B079EVL100500T1 Catalog Number :

Device Class : 2

Duns Number: 791890861

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

Inspiration 7i Ventilator System - B079EVM11000101US0 Catalog Number : F7300000-7i-L-US

Device Description : Inspiration Ventilator System, model 7i with 17" Display Panel

Device Class : 2

Duns Number: 791890861

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

Inspiration 7i Ventilator System - B079EVM11000102US0 Catalog Number : F7300000-7i-S-US

Device Description : Inspiration Ventilator System, model 7i with 12" Display Panel

Device Class : 2

Duns Number: 791890861

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

Inspiration 7i Ventilator System - B079EVM11000103US0 Catalog Number : F7300000-7i-F-US

Device Description : Inspiration Ventilator System, model 7i Flagship with 17" Display Panel

Device Class : 2

Duns Number: 791890861

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

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