MIR SRL MEDICAL INTERNATIONAL RESEARCH

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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

Meter, Peak Flow, Spirometry (BZH) (2) Spirometer, Diagnostic (BZG) (2)

Premarket Exempt

Clear

MIR - 08052990321674 Catalog Number : 911080GB

Device Description : Desktop base spirometer for lung function testing with Bluetooth function

Device Class : 2

Duns Number: 630129930

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

MIR - 08052990321681 Catalog Number :

Device Description : Peak low and FEV1 meter

Device Class : 2

Duns Number: 630129930

Premarket Exempt : No

Product Code : BZH

Prescription Use : No

Device Count : 1

Cohero - 08052990321728 Catalog Number : 911111

Device Description : Peak flow and FEV1 meter

Device Class : 2

Duns Number: 630129930

Premarket Exempt : No

Product Code : BZH

Prescription Use : No

Device Count : 1

MIR - 08052990321759 Catalog Number :

Device Description : Smart Spirometer connected to an app available on a smart phone

Device Class : 2

Duns Number: 630129930

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

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