Cognita Labs, LLC

Address:700 N MAIN ST,Santa Ana,CA,92701,US

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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

Impedance Measuring Device Utilizing Oscillation Techniques (PNV) (1) Spirometer, Monitoring (W/Wo Alarm) (BZK) (1)

Premarket Exempt

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CapMedic® - 00860003953709 Catalog Number :

Device Description : CapMedic is an interactive smart inhaler add-on that provides guidance for corre CapMedic is an interactive smart inhaler add-on that provides guidance for correct and regular use. The Bluetooth-connected device can also perform PEF and FEV1 tests to track lung function.

Device Class : 2

Duns Number: 079152829

Premarket Exempt : No

Product Code : BZK

Prescription Use : Yes

Device Count : 1

PulmoScan - 00860003953716 Catalog Number :

Device Description : PulmoScan is a portable wireless respiratory mechanics (resistance and reactance PulmoScan is a portable wireless respiratory mechanics (resistance and reactance) measurement device based on Forced Oscillometry. Bluetooth connectivity allows remote monitoring and visualization on mobile devices.

Device Class : 2

Duns Number: 079152829

Premarket Exempt : No

Product Code : PNV

Prescription Use : Yes

Device Count : 1

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