Shape Medical Systems, Inc.

Shape Medical Systems, Inc.

Address:MedTech Center/Shape Medical Systems, In,Saint Paul,MN,55110,US

Want to know more about this Organization? Request more information now!

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

Calculator, Predicted Values, Pulmonary Function (BTY) (8)

Premarket Exempt

No

Clear

Shape - B20040011 Catalog Number :

Device Description : Shape DPI

Device Class : 2

Duns Number: 021315587

Premarket Exempt : No

Product Code : BTY

Prescription Use : No

Device Count : 1

Shape-HF - B20044001 Catalog Number :

Device Description : Disposable Patient Interface is part of the Shape-HF testing system

Device Class : 2

Duns Number: 021315587

Premarket Exempt : No

Product Code : BTY

Prescription Use : No

Device Count : 1

Disposable Patient Interface with filter - B20044012 Catalog Number :

Device Description : Disposable patient interface with filter 0004-4012

Device Class : 2

Duns Number: 021315587

Premarket Exempt : No

Product Code : BTY

Prescription Use : Yes

Device Count : 1

Shape Vital Sign System - B20083012 Catalog Number :

Device Description : Full Shape II system with paramagnetic analyzer

Device Class : 2

Duns Number: 021315587

Premarket Exempt : No

Product Code : BTY

Prescription Use : No

Device Count : 1

Shape-HF - B20089001 Catalog Number :

Device Description : Shape-HF system

Device Class : 2

Duns Number: 021315587

Premarket Exempt : No

Product Code : BTY

Prescription Use : No

Device Count : 1

Shape II System Refurbished - B2009012 Catalog Number :

Device Description : Full Shape II system with paramagnetic analyzer

Device Class : 2

Duns Number: 021315587

Premarket Exempt : No

Product Code : BTY

Prescription Use : No

Device Count : 1

Shape-HF - B200HF001 Catalog Number :

Device Description : Shape-HF analyzer

Device Class : 2

Duns Number: 021315587

Premarket Exempt : No

Product Code : BTY

Prescription Use : No

Device Count : 1

Shape - B200HF012 Catalog Number :

Device Description : Paramagnetic Shape analyzer Product 0012

Device Class : 2

Duns Number: 021315587

Premarket Exempt : No

Product Code : BTY

Prescription Use : No

Device Count : 1

Previous 1 Next