Data / Medical devices / India / Fourth Frontier Technologies Private Limited
Fourth Frontier Technologies Private Limited: FDA-registered device maker in Bengaluru Karnataka, India, 1 510(k) clearance
Fourth Frontier Technologies Private Limited is registered with the FDA (registration 3032536454) in Bengaluru Karnataka, India. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 8, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3032536454
- Address
- 2nd and 3rd Floor, 794, 1st Cross, 12th Main Road HAL 2nd Stage, Indiranagar, Bengaluru Karnataka, India, 560038
- Owner or operator
- Fourth Frontier Technologies Private Limited (10092131)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- December 11, 2024
- Registered through
- 2026
- Brand names listed
- Frontier X Plus
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrocardiograph | DPS | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Electrocardiograph, Ambulatory, With Analysis Algorithm | MLO | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Transmitters And Receivers, Electrocardiograph, Telephone | DXH | 2 | Complaint file establishment, Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| November 8, 2024 | K240794 | Frontier X Plus | MLO | Substantially Equivalent | Fourth Frontier Technologies Pvt, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrocardiograph, Ambulatory, With Analysis Algorithm
- All makers of Electrocardiograph
- All makers of Transmitters And Receivers, Electrocardiograph, Telephone
Updated November 8, 2024. 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.