OSI OPTOELECTRONICS, INC.

Address:12525 Chadron Ave,Hawthorne,CA,90250,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

Oximeter (DQA) (10)

Premarket Exempt

Clear

Dolphin - 00859998006286 Catalog Number :

Device Description : Infant Disposable Oximetry Sensor

Device Class : 2

Duns Number: 612770974

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

Dolphin - 00859998006293 Catalog Number :

Device Description : Neonatal / Adult Disposable Oximetry Sensor

Device Class : 2

Duns Number: 612770974

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

BluSat - 00859998006347 Catalog Number :

Device Description : Y-Sensor

Device Class : 2

Duns Number: 612770974

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

BluSat - 00859998006354 Catalog Number :

Device Description : Reusable Ear-Clip

Device Class : 2

Duns Number: 612770974

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

BluSat - 00859998006361 Catalog Number :

Device Description : Adult Finger Sensor

Device Class : 2

Duns Number: 612770974

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

BluSat - 00859998006378 Catalog Number :

Device Description : Adult Finger Sensor

Device Class : 2

Duns Number: 612770974

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

BluSat - 00859998006408 Catalog Number :

Device Description : Patient Monitor Extension Cable

Device Class : 2

Duns Number: 612770974

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

TruLink - 00859998006439 Catalog Number : 21-00816

Device Description : SpO2 Finger Sensor Reusable - Adult

Device Class : 2

Duns Number: 612770974

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

TruLink - 00859998006446 Catalog Number : 21-00817

Device Description : SpO2 Y Multi-Site Sensor Reusable -Universal

Device Class : 2

Duns Number: 612770974

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

TruLink - 00859998006453 Catalog Number : 21-00809

Device Description : SpO2 Cloth Sensor Single-patient Use - Neonate

Device Class : 2

Duns Number: 612770974

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

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