Data / Medical devices / Vietnam / Given Imaging Vietnam Co., Ltd.
Given Imaging Vietnam Co., Ltd.: FDA-registered device maker in Ho Chi Minh City, Vietnam, 2 510(k) clearances
Given Imaging Vietnam Co., Ltd. is registered with the FDA (registration 3007662958) in Ho Chi Minh City, Vietnam. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 28, 2016. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3007662958
- Address
- Suite 6A, 6 floor, Standard Factory Bldg., 14th Street Tan Thuan EPZ, Tan Thuan Dong Ward, Ho Chi Minh City, Vietnam, District 7
- Owner or operator
- GIVEN IMAGING INC. (10091555)
- Roles
- Manufacturer
- First device listed
- October 15, 2024
- Registered through
- 2027
- Brand names listed
- AccuView pH & pH-Z software, Digitrapper pH Z, Disposable Balloons, ManoScan 3D HRM A300 module, ManoScan Impedance module (Z) A200, ManoScan System, ManoScan base pressure module ( A120), ManoScan sw and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Ph, Stomach | FFT | 1 | Manufacturer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Manufacturer | accessdata.fda.gov |
| Oximeter, Ear | DPZ | 2 | Manufacturer | accessdata.fda.gov |
| System, Gastrointestinal Motility (Electrical) | FFX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 28, 2016 | K151086 | ManoScan System | FFX | Substantially Equivalent | Given Imaging , Ltd. | accessdata.fda.gov |
| March 7, 2002 | K012891 | OXIMAX PULSE OXIMETRY SYSTEM WITH N-595 PULSE OXIMETER AND OXIMAX SENSORS AND CABLES (AKA ACCESSORIES) | DQA | Substantially Equivalent | Nellcor Puritan Bennett, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Oximeter, Ear
- All makers of Oximeter
- All makers of Electrode, Ph, Stomach
- All makers of System, Gastrointestinal Motility (Electrical)
Updated April 28, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.