MASIMO CORPORATION

Address:15776 Laguna Canyon Road,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) (10)

Premarket Exempt

No Yes

Clear

MasimoSET LNCS® DCI® SpO2 Adult Reusable Finger Clip Sensor - 00843997000406 Catalog Number :

Device Class : 2

Duns Number: 780421038

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

MasimoSET LNCS® DCI-P SpO2 Pediatric/Slender digit Reusable Finger Clip Sensor - 00843997000413 Catalog Number :

Device Class : 2

Duns Number: 780421038

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

SpO2.COM® RS-1 adult SpO2 reusable sensor - 00843997000505 Catalog Number :

Device Class : 2

Duns Number: 780421038

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

MasimoSET LNC-10 LNCS® Series Patient Cable - 00843997000512 Catalog Number :

Device Class : 2

Duns Number: 780421038

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

MasimoSET® LNCS® to PC Adapter Cable - 00843997000536 Catalog Number :

Device Class : 2

Duns Number: 780421038

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

MasimoSET LNC-14 LNCS® Series Patient Cable - 00843997000543 Catalog Number :

Device Class : 2

Duns Number: 780421038

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

MasimoSET LNC-10-GE LNCS® to GE Patient Cable - 00843997000550 Catalog Number :

Device Class : 2

Duns Number: 780421038

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

MasimoSET LNC-04 LNCS® Series Patient Cable - 00843997000567 Catalog Number :

Device Class : 2

Duns Number: 780421038

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

MasimoSET® LNC-4-EXT LNC Extension Cable - 00843997000574 Catalog Number :

Device Class : 2

Duns Number: 780421038

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

Rad-G - 00843997000666 Catalog Number :

Device Description : Rad-G, Continuous Pulse Oximeter

Device Class : 2

Duns Number: 780421038

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

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