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) (8) Electrocardiograph (DPS) (2) Mouthpiece, Breathing (BYP) (1) Spirometer, Diagnostic (BZG) (1)

Premarket Exempt

No Yes

Clear

SpiroSphere - 04057155000528 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 - 04057155000535 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 - 04057155000542 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 - 04057155000566 Catalog Number :

Device Description : Spirometer sensor to measure inspiratory and expiratory pulmonary function for c Spirometer sensor to measure inspiratory and expiratory pulmonary function for connection to software

Device Class : 2

Duns Number: 341625331

Premarket Exempt : No

Product Code : BTY

Prescription Use : Yes

Device Count : 1

Vyaire - 04057155000573 Catalog Number :

Device Description : Mouthpiece, V-892894 repackaged for Clinical Trial use

Device Class : 1

Duns Number: 341625331

Premarket Exempt : Yes

Product Code : BYP

Prescription Use : Yes

Device Count : 1

Asthma Monitor AMOS app - 04057155000603 Catalog Number :

Device Description : Accessory to ERT's Asthma Monitor device for professional users

Device Class : 2

Duns Number: 341625331

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

MasterScope - 04057155000610 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 - 04057155000627 Catalog Number :

Device Class : 2

Duns Number: 341625331

Premarket Exempt : No

Product Code : DPS, BTY

Prescription Use : Yes

Device Count : 1

MasterScope - 04057155000634 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 - 04057155000641 Catalog Number :

Device Class : 2

Duns Number: 341625331

Premarket Exempt : No

Product Code : BTY, DPS

Prescription Use : Yes

Device Count : 1

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