Data / Medical devices / Hong Kong / Tontec International Ltd.
Tontec International Ltd.: FDA-registered device maker in Kowloon Bay, Kowloon, Hong Kong, 1 510(k) clearance
Tontec International Ltd. is registered with the FDA (registration 3019834104) in Kowloon Bay, Kowloon, Hong Kong. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 15, 2009. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3019834104
- Address
- Unit1209-12, Telford House, Wang Hoi Road, Kowloon Bay, Kowloon, Hong Kong, 0000
- Owner or operator
- Tontec Precision Plastics Technology (Shenzhen) Co. Ltd. (10054549)
- Roles
- Exporter to the US
- First device listed
- March 31, 2017
- Registered through
- 2026
- Brand names listed
- Quick Connect SpO2 Clip, Adult, Quick Connect SpO2 Clip, Pediatric, Quick Connect SpO2 Grip, Adult, 20/box, Quick Connect SpO2 Grip, Infant, 20/box, Quick Connect SpO2 Grip, Neo, 20/box, Quick Connect SpO2 Grip, Ped, 20/box, Quick Connect SpO2 Starter Kit
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | 2 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| December 15, 2009 | K090785 | MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214 | MWI | Substantially Equivalent | Invivo Corp. | accessdata.fda.gov |
Compare with other makers
Updated December 15, 2009. 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.