IHEALTH LAB INC.

IHEALTH LAB INC.

Address:150C Charcot Ave,San Jose,CA,95131,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

System, Measurement, Blood-Pressure, Non-Invasive (DXN) (5) Instrument, Coagulation, Automated (GKP) (2) Analyzer, Body Composition, Exempt (PUH) (1) Coronavirus Antigen Detection Test System. (QKP) (1) Recorder, Magnetic Tape, Medical (DSH) (1)

Premarket Exempt

No Yes

Clear

iHealth - 00850044118007 Catalog Number :

Device Class :

Duns Number: 054953337

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

iHealth - 00850044118021 Catalog Number :

Device Class :

Duns Number: 054953337

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

iHealth - 00850044118038 Catalog Number :

Device Class : 2

Duns Number: 054953337

Premarket Exempt : Yes

Product Code : PUH

Prescription Use : No

Device Count : 1

iHealth - 00850044118045 Catalog Number :

Device Class :

Duns Number: 054953337

Premarket Exempt : Yes

Product Code : GKP

Prescription Use : No

Device Count : 1

iHealth - 00850044118052 Catalog Number :

Device Class :

Duns Number: 054953337

Premarket Exempt : Yes

Product Code : GKP

Prescription Use : No

Device Count : 1

iHealth - 00850044118069 Catalog Number :

Device Class :

Duns Number: 054953337

Premarket Exempt : Yes

Product Code : QKP

Prescription Use : No

Device Count : 1

iHealth - 00855111003040 Catalog Number :

Device Class :

Duns Number: 054953337

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

iHealth - 00855111003958 Catalog Number :

Device Class :

Duns Number: 054953337

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

iHealth - 00856362005005 Catalog Number :

Device Class :

Duns Number: 054953337

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

iHealth - 00856362005012 Catalog Number :

Device Class : 2

Duns Number: 054953337

Premarket Exempt : No

Product Code : DSH

Prescription Use : No

Device Count : 1

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