eResearchTechnology GmbH

Address:Sieboldstrasse 3,Estenfeld Bavaria,DE

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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) (4)

Premarket Exempt

No Yes

Clear

SpiroSphere - 04057155000719 Catalog Number :

Device Description : Main Unit of diagnostic spirometer for measurement and data collection of lung f Main Unit of diagnostic spirometer for measurement and data collection of lung function parameters

Device Class : 2

Duns Number: 341625331

Premarket Exempt : No

Product Code : BTY

Prescription Use : Yes

Device Count : 1

SpiroSphere - 04057155000726 Catalog Number :

Device Description : Diagnostic spirometer for measurement and data collection of lung function parameters

Device Class : 2

Duns Number: 341625331

Premarket Exempt : No

Product Code : BTY

Prescription Use : Yes

Device Count : 1

SpiroSphere - 04057155000757 Catalog Number :

Device Description : Diagnostic spirometer for measurement and data collection of lung function parameters

Device Class : 2

Duns Number: 341625331

Premarket Exempt : No

Product Code : BTY

Prescription Use : Yes

Device Count : 1

SpiroSphere - 04057155000764 Catalog Number :

Device Description : Diagnostic spirometer for measurement and data collection of lung function parameters

Device Class : 2

Duns Number: 341625331

Premarket Exempt : No

Product Code : BTY

Prescription Use : Yes

Device Count : 1

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