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) (7) Electrocardiograph (DPS) (2) Spirometer, Diagnostic (BZG) (2)

Premarket Exempt

No Yes

Clear

MasterScope - 04057155000016 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

MasterScope - 04057155000023 Catalog Number :

Device Description : diagnostic spirometer for measurement and data collection of lung function param diagnostic spirometer for measurement and data collection of lung function parameters in Clinical Trials

Device Class : 2

Duns Number: 341625331

Premarket Exempt : No

Product Code : BTY

Prescription Use : Yes

Device Count : 1

MasterScope - 04057155000030 Catalog Number :

Device Class : 2

Duns Number: 341625331

Premarket Exempt : No

Product Code : DPS, BTY

Prescription Use : Yes

Device Count : 1

MasterScope ECG - 04057155000054 Catalog Number :

Device Description : diagnostic device for ECG measurement and data collection

Device Class : 2

Duns Number: 341625331

Premarket Exempt : No

Product Code : DPS

Prescription Use : Yes

Device Count : 1

MasterScope - 04057155000061 Catalog Number :

Device Description : Spirometer handle to measure inspiratory and expiratory pulmonary function; part Spirometer handle to measure inspiratory and expiratory pulmonary function; part of MasterScope and MasterScope CT

Device Class : 2

Duns Number: 341625331

Premarket Exempt : No

Product Code : BTY

Prescription Use : Yes

Device Count : 1

Pneumotach - 04057155000078 Catalog Number :

Device Description : Pneumotachograph, accessory to spirometer handle

Device Class : 2

Duns Number: 341625331

Premarket Exempt : No

Product Code : BTY

Prescription Use : No

Device Count : 1

FlowScreen - 04057155000122 Catalog Number :

Device Description : diagnostic spirometer for recording and assessing pulmonary function

Device Class : 2

Duns Number: 341625331

Premarket Exempt : No

Product Code : BTY

Prescription Use : Yes

Device Count : 1

FlowScreen - 04057155000139 Catalog Number :

Device Description : diagnostic spirometer for recording and assessing pulmonary function

Device Class : 2

Duns Number: 341625331

Premarket Exempt : No

Product Code : BTY

Prescription Use : Yes

Device Count : 1

Asthma Monitor AM1+ - 04057155000177 Catalog Number :

Device Description : Asthma Monitor, electronic peak flow meter

Device Class : 2

Duns Number: 341625331

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

Asthma Monitor AM3 - 04057155000191 Catalog Number :

Device Description : Asthma Monitor, electronic peak flow meter

Device Class : 2

Duns Number: 341625331

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

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