C O S M E D SRL

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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

Calculator, Predicted Values, Pulmonary Function (BTY) (6) Calculator, Pulmonary Function Data (BZC) (3) Ventilator, Continuous, Facility Use (CBK) (3) Oximeter (DQA) (2) Spirometer, Diagnostic (BZG) (2)

Premarket Exempt

Clear

COSMED - 18052400180034 Catalog Number :

Device Description : The COSMED microQuark pulmonary function testing system is a modular laboratory

Device Class : 2

Duns Number: 438896136

Premarket Exempt : No

Product Code : BTY, BZC

Prescription Use : Yes

Device Count : 1

COSMED - 18052400180041 Catalog Number :

Device Description : The COSMED Pony FX pulmonary function testing system is a standalone and modular

Device Class : 2

Duns Number: 438896136

Premarket Exempt : No

Product Code : DQA, BTY

Prescription Use : Yes

Device Count : 1

COSMED - 18052400180058 Catalog Number :

Device Description : The COSMED Pony FX pulmonary function testing system is a standalone and modular

Device Class : 2

Duns Number: 438896136

Premarket Exempt : No

Product Code : DQA, BTY

Prescription Use : Yes

Device Count : 1

COSMED - 18052400180065 Catalog Number :

Device Description : The COSMED Quark Series system Is a modular system with multiple configurations,

Device Class : 2

Duns Number: 438896136

Premarket Exempt : No

Product Code : BTY, CBK

Prescription Use : Yes

Device Count : 1

COSMED - 18052400180072 Catalog Number :

Device Description : The COSMED Spiropalm pulmonary function testing systems are spirometers for perf

Device Class : 2

Duns Number: 438896136

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

COSMED - 18052400180096 Catalog Number :

Device Description : The COSMED Spiropalm pulmonary function testing systems are spirometers for perf

Device Class : 2

Duns Number: 438896136

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

COSMED - 18052400180126 Catalog Number :

Device Description : The Cosmed K4b2 is a metabolic measurement system that allows telemetry monitori

Device Class : 2

Duns Number: 438896136

Premarket Exempt : No

Product Code : BZC

Prescription Use : Yes

Device Count : 1

COSMED - 18052400180157 Catalog Number :

Device Description : The Cosmed K4b2 is a metabolic measurement system that allows telemetry monitori

Device Class : 2

Duns Number: 438896136

Premarket Exempt : No

Product Code : BZC

Prescription Use : Yes

Device Count : 1

COSMED - 18052400180164 Catalog Number :

Device Description : The COSMED Quark Series system Is a modular system with multiple configurations,

Device Class : 2

Duns Number: 438896136

Premarket Exempt : No

Product Code : BTY, CBK

Prescription Use : Yes

Device Count : 1

COSMED - 18052400180171 Catalog Number :

Device Description : The COSMED Quark Series system Is a modular system with multiple configurations,

Device Class : 2

Duns Number: 438896136

Premarket Exempt : No

Product Code : BTY, CBK

Prescription Use : Yes

Device Count : 1

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