Data / Medical devices / China / General Meditech, Inc.
General Meditech, Inc.: FDA-registered device maker in Shenzhen Guangdong, China, 2 510(k) clearances
General Meditech, Inc. is registered with the FDA (registration 3006147705) in Shenzhen Guangdong, China. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 2, 2010. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006147705
- Address
- South Office 4/F,Kezhi 1st.Rd west, Science Park Nanshan, Shenzhen Guangdong, China, 518057
- Owner or operator
- GENERAL MEDITECH, INC. (10028583)
- Roles
- Manufacturer
- First device listed
- February 12, 2009
- Registered through
- 2026
- Brand names listed
- G3M, G3N, G3R, G3S, Model: G1B and G1B Plus, Model: G3C, G3D, G3F, G3G, G3H, G3L and G2A
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | 2 | Manufacturer | accessdata.fda.gov |
| Oximeter | DQA | 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 |
|---|---|---|---|---|---|---|
| February 2, 2010 | K092970 | GENERAL PATIENT MONITORS, MODELS: G3C/ G3D/ G3F/ G3G/ G3H | MHX | Substantially Equivalent | General Meditech, Inc. | accessdata.fda.gov |
| January 7, 2009 | K082789 | G1B PULSE OXIMETER | DQA | Substantially Equivalent | General Meditech, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Oximeter
- All makers of Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Updated February 2, 2010. 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.