LEADTEK RESEARCH, INC.

Address:2F, No.4, Alley 11, Lane 327, Sec. 2, Chung San Rd., Chung Ho Dist.,New Taipei City,TW

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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) (2) Oximeter, Infrared, Sporting, Aviation (OCH) (2)

Premarket Exempt

No Yes

Clear

Leadtek - 00190263830114 Catalog Number :

Device Class : 2

Duns Number: 656171121

Premarket Exempt : Yes

Product Code : OCH

Prescription Use : No

Device Count : 1

Leadtek - 00190263830121 Catalog Number :

Device Class : 2

Duns Number: 656171121

Premarket Exempt : Yes

Product Code : OCH

Prescription Use : No

Device Count : 1

Alvital - 00190263830138 Catalog Number :

Device Class : 2

Duns Number: 656171121

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

Alvital - 00190263830145 Catalog Number :

Device Class : 2

Duns Number: 656171121

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

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