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) (9) Wire, Guide, Catheter (DQX) (3)

Premarket Exempt

Clear

OptoMonitor - 07540184020201 Catalog Number : F2020

Device Class : 2

Duns Number: 253717946

Premarket Exempt : No

Product Code : DQX, DXO

Prescription Use : Yes

Device Count : 1

OptoMonitor - 07540184020300 Catalog Number : F2030

Device Class : 2

Duns Number: 253717946

Premarket Exempt : No

Product Code : DXO, DQX

Prescription Use : Yes

Device Count : 1

OptoMonitor 3 - 07540184023103 Catalog Number : F2310

Device Class : 2

Duns Number: 253717946

Premarket Exempt : No

Product Code : DXO

Prescription Use : Yes

Device Count : 1

OptoMonitor 3 - 07540184023202 Catalog Number : F2320

Device Class : 2

Duns Number: 253717946

Premarket Exempt : No

Product Code : DXO

Prescription Use : Yes

Device Count : 1

OptoMonitor 3 - 07540184023219 Catalog Number : F2321

Device Class : 2

Duns Number: 253717946

Premarket Exempt : No

Product Code : DXO

Prescription Use : Yes

Device Count : 1

OptoMonitor - 07540184023226 Catalog Number :

Device Description : OpM3-DU Wireless dongle

Device Class : 2

Duns Number: 253717946

Premarket Exempt : No

Product Code : DXO

Prescription Use : Yes

Device Count : 1

OptoMonitor 3 - 07540184023301 Catalog Number : F2330

Device Class : 2

Duns Number: 253717946

Premarket Exempt : No

Product Code : DXO

Prescription Use : Yes

Device Count : 1

OptoWire - 07540184110124 Catalog Number : F1012

Device Description : Pressure guidewire

Device Class :

Duns Number: 253717946

Premarket Exempt : No

Product Code : DXO, DQX

Prescription Use : Yes

Device Count : 1

OptoMonitor 3 - 07540184132010 Catalog Number : F232010

Device Class : 2

Duns Number: 253717946

Premarket Exempt : No

Product Code : DXO

Prescription Use : Yes

Device Count : 1

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