Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007662958

FEI Number

3007662958

Entity Name

Given Imaging Vietnam Co., Ltd.

City/State/Country

Ho Chi Minh City, VN

Establishment Address

Suite 6A, 6 floor, Standard Factory Bldg., 14th Street, Tan Thuan EPZ, Tan Thuan Dong Ward, Ho Chi Minh City District 7, VN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GIVEN IMAGING INC. (Owner Number: 10091555)

Owner / Operator Contact Address

15 HAMPSHIRE STREET, Mansfield, MA 02048, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K151086

PMA Number

N/A

All Registered Proprietary Names

Oximax Pulse Oximetry System Disposable Balloons Manoscan catheters ManoScan sw ManoView AR sw ManoScan Impedance module (Z) A200 ManoShield (disposable sanitary sheaths) ManoView ESO sw ManoScan 3D HRM A300 module ManoScan base pressure module ( A120) ManoScan System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DPZ	Oximeter, Ear	Cardiovascular	Class 2	870.2710	2024-10-15
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2024-10-15
FFX	System, Gastrointestinal Motility (Electrical)	Gastroenterology, Urology	Class 2	876.1725	2024-10-15

Official Correspondent

AVISHAG METZER

US Agent Details

Marsha Seetaram Business: Medtronic, Inc. Email: marsha.n.seetaram@medtronic.com Phone: (904) 2812763

Related Public Records

Same Entity

GIVEN IMAGING INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9710107	GIVEN IMAGING LTD.	Yoqneam Northern, IL

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K903523	Hewlett-Packard Co.	HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE	1990-10-23
K973147	Nellcor Puritan Bennett, Inc.	NPB-295 PULSE OXIMETER	1997-11-14
K231243	Guangdong Genial Technology Co., Ltd.	Finger Clip Pulse Oximeter	2023-10-31
K971628	Somanetics Corp.	SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)	1997-10-10
K153184	Shenzhen Caremed Medical Technology Co., Ltd.	Caremed Reusable & Disposable SPO2 Sensors	2017-01-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M, Part Number CS08653
Z-0029-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M W/PRINTER, Part Number CS08659

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3013188547	ORTA MEDICAL LTD	TZUR YIGAL Central, IL
3009831876	MASIMO CORPORATION	Irvine, CA, US
3008729547	GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V.	JUAREZ Chihuahua, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007662958. Last updated year: 2026. Please use registration number 3007662958 when referencing this establishment in official correspondence.