Samsung Electronics Co., Ltd.

Address:129, Samsung-ro, Yeongtong-gu,Suwon-si Gyeonggi,KR

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

Solid State X-Ray Imager (Flat Panel/Digital Imager) (MQB) (7) System, X-Ray, Stationary (KPR) (3) Electrocardiograph Software For Over-The-Counter Use (QDA) (2) Analyzer, Body Composition, Exempt (PUH) (1) System, X-Ray, Mobile (IZL) (1)

Premarket Exempt

No Yes

Clear

NA - 08806088538440 Catalog Number :

Device Description : The GR40CW Digital X-ray Imaging System is intended for use in general projectio The GR40CW Digital X-ray Imaging System is intended for use in general projection radiographic applications wherever conventional screen-film systems or CR systems may be used. This device is not intended for mammographic applications.

Device Class : 2

Duns Number: 687967554

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

NA - 08806088565231 Catalog Number :

Device Description : The GC85A Digital X-ray Imaging System is intended for use in generating radiogr The GC85A Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.

Device Class : 2

Duns Number: 687967554

Premarket Exempt : No

Product Code : KPR, MQB

Prescription Use : Yes

Device Count : 1

NA - 08806088566313 Catalog Number :

Device Description : The GU60A Digital X-ray Imaging Systems are intended for use in generating radio The GU60A Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.

Device Class : 2

Duns Number: 687967554

Premarket Exempt : No

Product Code : KPR, MQB

Prescription Use : Yes

Device Count : 1

NA - 08806088582412 Catalog Number :

Device Description : The GM85 Digital X-ray imaging System is intended for use in generating radiogra The GM85 Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.

Device Class : 2

Duns Number: 687967554

Premarket Exempt : No

Product Code : MQB, IZL

Prescription Use : Yes

Device Count : 1

NA - 08806088670560 Catalog Number :

Device Description : The GC70 Digital X-ray Imaging System is intended for use in generating radiogra The GC70 Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.

Device Class : 2

Duns Number: 687967554

Premarket Exempt : No

Product Code : KPR, MQB

Prescription Use : Yes

Device Count : 1

NA - 08806088773797 Catalog Number :

Device Class : 2

Duns Number: 687967554

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

NA - 08806090171147 Catalog Number :

Device Description : The GR40CW and GR40CWD Digital X-ray Imaging System is intended for use in gener The GR40CW and GR40CWD Digital X-ray Imaging System is intended for use in general projection radiographic applications wherever conventional screen-film systems or CR systems may be used. This device is not intended for mammographic applications.

Device Class : 2

Duns Number: 687967554

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

Samsung ECG Monitor Application - 08806090792021 Catalog Number :

Device Class : 2

Duns Number: 687967554

Premarket Exempt : No

Product Code : QDA

Prescription Use : No

Device Count : 1

Samsung ECG Monitor Application - 08806090792045 Catalog Number :

Device Class : 2

Duns Number: 687967554

Premarket Exempt : No

Product Code : QDA

Prescription Use : No

Device Count : 1

Samsung Health Body Composition - 08806092938847 Catalog Number :

Device Description : Samsung Health Body Composition tracker for android OS smart phone

Device Class : 2

Duns Number: 687967554

Premarket Exempt : Yes

Product Code : PUH

Prescription Use : No

Device Count : 1

Previous 1 2 3 4 Next