LUTECH INDUSTRIES INC

Address:105 Remington Blvd Suite C,Ronkonkoma,NY,11779,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

Electrocardiograph (DPS) (10) Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms) (MWI) (10) Oximeter (DQA) (10) System, Measurement, Blood-Pressure, Non-Invasive (DXN) (10) Thermometer, Electronic, Clinical (FLL) (10)

Premarket Exempt

Clear

Lutech - B299780MIPM0 Catalog Number :

Device Description : Multi-parameter patient monitor. 780-M-I-pM

Device Class : 2

Duns Number: 078698036

Premarket Exempt : No

Product Code : DPS, FLL, DQA, MWI, DXN

Prescription Use : No

Device Count : 1

Lutech - B299780MIPMO20 Catalog Number :

Device Description : Multi-parameter patient monitor. 780-M-I-pMO2

Device Class : 2

Duns Number: 078698036

Premarket Exempt : No

Product Code : DXN, MWI, DQA, FLL, DPS

Prescription Use : No

Device Count : 1

Lutech - B299780MIPMO2P0 Catalog Number :

Device Description : Multi-parameter patient monitor. 780-M-I-pMO2-P

Device Class : 2

Duns Number: 078698036

Premarket Exempt : No

Product Code : DPS, FLL, DQA, MWI, DXN

Prescription Use : No

Device Count : 1

Lutech - B299780MIPMP0 Catalog Number :

Device Description : Multi-parameter patient monitor. 780-M-I-pM-P

Device Class : 2

Duns Number: 078698036

Premarket Exempt : No

Product Code : DXN, MWI, DQA, FLL, DPS

Prescription Use : No

Device Count : 1

Lutech - B299780MP0 Catalog Number :

Device Description : Multi-parameter patient monitor. 780-M-P

Device Class : 2

Duns Number: 078698036

Premarket Exempt : No

Product Code : DXN, MWI, DQA, FLL, DPS

Prescription Use : No

Device Count : 1

Lutech - B299780MPM0 Catalog Number :

Device Description : Multi-parameter patient monitor. 780-M-pM

Device Class : 2

Duns Number: 078698036

Premarket Exempt : No

Product Code : DXN, MWI, DQA, FLL, DPS

Prescription Use : No

Device Count : 1

Lutech - B299780MPMO20 Catalog Number :

Device Description : Multi-parameter patient monitor. 780-M-pMO2

Device Class : 2

Duns Number: 078698036

Premarket Exempt : No

Product Code : DPS, FLL, DQA, MWI, DXN

Prescription Use : No

Device Count : 1

Lutech - B299780MPMO2P0 Catalog Number :

Device Description : Multi-parameter patient monitor. 780-M-pMO2-P

Device Class : 2

Duns Number: 078698036

Premarket Exempt : No

Product Code : DXN, MWI, DQA, FLL, DPS

Prescription Use : No

Device Count : 1

Lutech - B299780MPMP0 Catalog Number :

Device Description : Multi-parameter patient monitor. 780-M-pM-P

Device Class : 2

Duns Number: 078698036

Premarket Exempt : No

Product Code : DPS, FLL, DQA, MWI, DXN

Prescription Use : No

Device Count : 1

Lutech - B299780N0 Catalog Number :

Device Description : Multi-parameter patient monitor. 780-N

Device Class : 2

Duns Number: 078698036

Premarket Exempt : No

Product Code : DXN, MWI, DQA, FLL, DPS

Prescription Use : No

Device Count : 1

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