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) (8) Oximeter, ear (DPZ) (2)

Premarket Exempt

No Yes

Clear

MasimoSET LNCS® TC-I SpO2 Reusable Ear Sensor - 00843997000048 Catalog Number :

Device Class : 2

Duns Number: 780421038

Premarket Exempt : No

Product Code : DPZ

Prescription Use : Yes

Device Count : 1

MasimoSET® LNCS® TF-I SpO2 Reusable Forehead Sensor - 00843997000055 Catalog Number :

Device Class : 2

Duns Number: 780421038

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

MasimoSET LNCS® YI SpO2 Multisite Reusable Sensor - 00843997000062 Catalog Number :

Device Class : 2

Duns Number: 780421038

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

LNOP® DC-195 SpO2 Adult Reusable Sensor - 00843997000086 Catalog Number :

Device Class : 2

Duns Number: 780421038

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

MasimoSET® LNOP® DCI® SpO2 Adult Reusable Finger Clip Sensor - 00843997000093 Catalog Number :

Device Class : 2

Duns Number: 780421038

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

DCSC SpO2 Adult Reusable Sensor - 00843997000109 Catalog Number :

Device Class : 2

Duns Number: 780421038

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

MasimoSET® LNOP® TF-I SpO2 Adult Reusable Forehead Sensor - 00843997000208 Catalog Number :

Device Class : 2

Duns Number: 780421038

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

MasimoSET® LNOP® YI SpO2 Multisite Reusable Sensor - 00843997000215 Catalog Number :

Device Class : 2

Duns Number: 780421038

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

MasimoSET® LNOP® DCI-P® SpO2 Pediatric/Slender digit Reusable Finger Clip Sensor - 00843997000222 Catalog Number :

Device Class : 2

Duns Number: 780421038

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

MasimoSET® LNOP® TC-I SpO2 Reusable Ear Sensor - 00843997000239 Catalog Number :

Device Class : 2

Duns Number: 780421038

Premarket Exempt : No

Product Code : DPZ

Prescription Use : Yes

Device Count : 1

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