Data / Medical devices / China / Biox Instruments Co Ltd
Biox Instruments Co Ltd: FDA-registered device maker in Wuxi Jiangsu, China, 4 510(k) clearances
Biox Instruments Co Ltd is registered with the FDA (registration 3007663004) in Wuxi Jiangsu, China. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated June 28, 2011. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3007663004
- Address
- 100 Dicui Road, 530 Building 1, 19th Floor Binhu District, Wuxi Jiangsu, China, 214072
- Owner or operator
- VASOMEDICAL, INC. (2435300)
- Roles
- Manufacturer
- First device listed
- May 4, 2009
- Registered through
- 2026
- Brand names listed
- Biox, Model 1305, ARCS, Models 1303, 1304, 1306,1307,1308, ARCS, Models 1804, 1805, 1806, 1807, 2302, 2303, 2304, 2305, 2306, ARCS, Vasomedical-Biox 2301 ABPECG Record, ARCS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Recorder, Magnetic Tape, Medical | DSH | 2 | Manufacturer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 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 |
|---|---|---|---|---|---|---|
| June 28, 2011 | K111180 | VASOMEDICAL-BIOX 12- CHANNEL AMBULATORY ECG HOLTER RECORDER MODEL 1304, VASOMEDICAL-BIOX 3- CHANNEL MINIATURE AMBULATORY | DSH | Substantially Equivalent | Vasomedical, Inc. | accessdata.fda.gov |
| June 24, 2011 | K111096 | VASOMEDICAL-BIOX COMBINED 12 CHANNEL AMBULATORY ECG AND BLOOD PRESSURE RECORDER MODEL 2302, VASOMEDICAL-BIOX AMBULATORY | DSH | Substantially Equivalent | Vasomedical, Inc. | accessdata.fda.gov |
| April 2, 2010 | K092785 | COMBINED VASOMEDICAL-BIOX AMBULATORY ECG & BLOOD PRESSURE RECORDER & ANALYSIS SOFTWARE, 2301 | DSH | Substantially Equivalent | Vasomedical, Inc. | accessdata.fda.gov |
| April 1, 2009 | K083820 | VASOMEDICAL BIOX CB-1305-C, 3 CHANNEL ECG HOLTER MONITOR, MODEL CB-1305-C | DSH | Substantially Equivalent | Vasomedical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Recorder, Magnetic Tape, Medical
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
Updated June 28, 2011. 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.