Given Imaging, Inc.

Address:15 Hampshire Street,Mansfield,MA,02048,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

SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) (FFX) (4) SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE (NEZ) (2) Electrode, pH, stomach (FFT) (1)

Premarket Exempt

No Yes

Clear

RAPID - 07290101365013 Catalog Number :

Device Description : SW kit, v8.0 SCA WS

Device Class : 2

Duns Number: 090073722

Premarket Exempt : No

Product Code : NEZ

Prescription Use : No

Device Count : 1

VersaFlex - 07290101365167 Catalog Number :

Device Description : catheter, LPR starter kit

Device Class : 1

Duns Number: 090073722

Premarket Exempt : Yes

Product Code : FFT

Prescription Use : No

Device Count : 1

NA - 07290101365396 Catalog Number :

Device Description : PDU, cal chamber mounting kit

Device Class : 2

Duns Number: 090073722

Premarket Exempt : No

Product Code : FFX

Prescription Use : No

Device Count : 1

NA - 07290101365655 Catalog Number :

Device Description : Monitor, Dell P2214H 22 LED

Device Class : 2

Duns Number: 090073722

Premarket Exempt : No

Product Code : FFX

Prescription Use : No

Device Count : 1

PillCam - 07290101365686 Catalog Number :

Device Description : sensor array, DR2 8-lead

Device Class : 2

Duns Number: 090073722

Premarket Exempt : No

Product Code : NEZ

Prescription Use : No

Device Count : 1

ManoScan - 07290101365709 Catalog Number : 800000

Device Description : accessory kit

Device Class : 2

Duns Number: 090073722

Premarket Exempt : No

Product Code : FFX

Prescription Use : No

Device Count : 1

GIFD - 07290110361068 Catalog Number :

Device Description : GIFD laptop, Win 10 with SW

Device Class : 2

Duns Number: 090073722

Premarket Exempt : Yes

Product Code : FFX

Prescription Use : Yes

Device Count : 1

Previous 1 … 4 5 6 7 8 Next