Opsens Inc

Address:750, Boulevard du Parc Technologique,Quebec City,CA

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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

Transducer, Pressure, Catheter Tip (DXO) (10) Wire, Guide, Catheter (DQX) (7)

Premarket Exempt

Clear

OptoMonitor - 07540184012091 Catalog Number : F201209

Device Class : 2

Duns Number: 253717946

Premarket Exempt : No

Product Code : DXO, DQX

Prescription Use : Yes

Device Count : 1

OptoMonitor - 07540184012107 Catalog Number : F201210

Device Class : 2

Duns Number: 253717946

Premarket Exempt : No

Product Code : DXO, DQX

Prescription Use : Yes

Device Count : 1

OptoMonitor - 07540184012114 Catalog Number : F201211

Device Class : 2

Duns Number: 253717946

Premarket Exempt : No

Product Code : DXO, DQX

Prescription Use : Yes

Device Count : 1

OptoMonitor - 07540184012121 Catalog Number : F201212

Device Class : 2

Duns Number: 253717946

Premarket Exempt : No

Product Code : DXO, DQX

Prescription Use : Yes

Device Count : 1

OptoMonitor - 07540184012138 Catalog Number : F201213

Device Class : 2

Duns Number: 253717946

Premarket Exempt : No

Product Code : DXO, DQX

Prescription Use : Yes

Device Count : 1

OptoMonitor - 07540184020010 Catalog Number : F202001

Device Class : 2

Duns Number: 253717946

Premarket Exempt : No

Product Code : DXO, DQX

Prescription Use : Yes

Device Count : 1

OptoMonitor 3 - 07540184020096 Catalog Number : F232009

Device Class : 2

Duns Number: 253717946

Premarket Exempt : No

Product Code : DXO

Prescription Use : Yes

Device Count : 1

OptoMonitor - 07540184020102 Catalog Number : F2010

Device Class : 2

Duns Number: 253717946

Premarket Exempt : No

Product Code : DXO, DQX

Prescription Use : Yes

Device Count : 1

OptoMonitor 3 - 07540184020119 Catalog Number : F232011

Device Class : 2

Duns Number: 253717946

Premarket Exempt : No

Product Code : DXO

Prescription Use : Yes

Device Count : 1

OptoMonitor 3 - 07540184020126 Catalog Number : F232012

Device Class : 2

Duns Number: 253717946

Premarket Exempt : No

Product Code : DXO

Prescription Use : Yes

Device Count : 1

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