MASIMO CORPORATION

Address:9600 Jeronimo,Irvine,CA,92618,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) (9) Oximeter, ear (DPZ) (1)

Premarket Exempt

No Yes

Clear

SpO2.COM® NRC-GE Patient Cable - 00843997001397 Catalog Number :

Device Class : 2

Duns Number: 780421038

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

SpO2.COM® NRC-SL Spacelabs Replacement Cable - 00843997001410 Catalog Number :

Device Class : 2

Duns Number: 780421038

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

SpO2.COM® NRC-P8 Patient Cable, 3M - 00843997001427 Catalog Number :

Device Class : 2

Duns Number: 780421038

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

SpO2.COM® NRC-SL2 Spacelabs Replacement Cable - 00843997001434 Catalog Number :

Device Class : 2

Duns Number: 780421038

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

MasimoSET® Accessory Ear Clip - 00843997001540 Catalog Number :

Device Class : 2

Duns Number: 780421038

Premarket Exempt : Yes

Product Code : DPZ

Prescription Use : Yes

Device Count : 1

MasimoSET Red LNC-01 LNCS® Patient Cable - 00843997001557 Catalog Number :

Device Class : 2

Duns Number: 780421038

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

MasimoSET LNC-01 LNCS® Series Patient Cable - 00843997001564 Catalog Number :

Device Class : 2

Duns Number: 780421038

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

Radical Docking Station RDS-1 signal extraction pulse oximeter - 00843997001571 Catalog Number :

Device Description : The device has the Direct Mark DI of: 00843997013802

Device Class :

Duns Number: 780421038

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

Radical Docking Station RDS-2 signal extraction pulse oximeter - 00843997001588 Catalog Number :

Device Class : 2

Duns Number: 780421038

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

Radical Docking Station RDS-3 signal extraction pulse oximeter - 00843997001595 Catalog Number :

Device Class :

Duns Number: 780421038

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

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