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

TruLink - 00859998006460 Catalog Number : 21-00810

Device Description : SpO2 Cloth Sensor Single-Patient Use - Infant

Device Class : 2

Duns Number: 612770974

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

TruLink - 00859998006477 Catalog Number : 21-00811

Device Description : SpO2 Foam Sensor Single-Patient Use - Pediatric

Device Class : 2

Duns Number: 612770974

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

TruLink - 00859998006484 Catalog Number : 21-00812

Device Description : SpO2 Vinyl Sensor Single-patient Use - Pediatric

Device Class : 2

Duns Number: 612770974

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

TruLink - 00859998006491 Catalog Number : 21-00813

Device Description : SpO2 Foam Sensor Single-patient Use Adult

Device Class : 2

Duns Number: 612770974

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

TruLink - 00859998006507 Catalog Number : 21-0814

Device Description : SpO2 Vinyl Sensor Single-Patient Use - Adult

Device Class : 2

Duns Number: 612770974

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

BluSat - 10859998006306 Catalog Number :

Device Description : Gentle Touch Adult Fabric Sensor

Device Class : 2

Duns Number: 612770974

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

BluSat - 10859998006313 Catalog Number :

Device Description : Gentle Touch Pediatric Fabric Sensor

Device Class : 2

Duns Number: 612770974

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

BluSat - 10859998006320 Catalog Number :

Device Description : Gentle Touch Infant Fabric Sensor

Device Class : 2

Duns Number: 612770974

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

BluSat - 10859998006337 Catalog Number :

Device Description : Gentle Touch Neonatal Fabric Sensor

Device Class : 2

Duns Number: 612770974

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

BluSat - 10859998006412 Catalog Number :

Device Description : Adhesive Sensor Wrap, Universal

Device Class : 2

Duns Number: 612770974

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

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