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) (10)

Premarket Exempt

Clear

OptoMonitor - 07540184011087 Catalog Number : F201108

Device Class : 2

Duns Number: 253717946

Premarket Exempt : No

Product Code : DXO, DQX

Prescription Use : Yes

Device Count : 1

OptoMonitor - 07540184011094 Catalog Number : F201109

Device Class : 2

Duns Number: 253717946

Premarket Exempt : No

Product Code : DXO, DQX

Prescription Use : Yes

Device Count : 1

OptoMonitor - 07540184011100 Catalog Number : F201110

Device Class : 2

Duns Number: 253717946

Premarket Exempt : No

Product Code : DXO, DQX

Prescription Use : Yes

Device Count : 1

OptoMonitor - 07540184011117 Catalog Number : F201111

Device Class : 2

Duns Number: 253717946

Premarket Exempt : No

Product Code : DXO, DQX

Prescription Use : Yes

Device Count : 1

OptoMonitor - 07540184011124 Catalog Number : F201112

Device Class : 2

Duns Number: 253717946

Premarket Exempt : No

Product Code : DXO, DQX

Prescription Use : Yes

Device Count : 1

OptoMonitor - 07540184012015 Catalog Number : F201201

Device Class : 2

Duns Number: 253717946

Premarket Exempt : No

Product Code : DXO, DQX

Prescription Use : Yes

Device Count : 1

OptoMonitor - 07540184012022 Catalog Number : F201202

Device Class : 2

Duns Number: 253717946

Premarket Exempt : No

Product Code : DXO, DQX

Prescription Use : Yes

Device Count : 1

OptoMonitor - 07540184012039 Catalog Number : F201203

Device Class : 2

Duns Number: 253717946

Premarket Exempt : No

Product Code : DXO, DQX

Prescription Use : Yes

Device Count : 1

OptoMonitor - 07540184012046 Catalog Number : F201204

Device Class : 2

Duns Number: 253717946

Premarket Exempt : No

Product Code : DXO, DQX

Prescription Use : Yes

Device Count : 1

OptoMonitor - 07540184012053 Catalog Number : F201205

Device Class : 2

Duns Number: 253717946

Premarket Exempt : No

Product Code : DXO, DQX

Prescription Use : Yes

Device Count : 1

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