Data / Medical devices / India / Tekna Manufacturing Pvt. Ltd.
Tekna Manufacturing Pvt. Ltd.: FDA-registered device maker in Chennai Tamil Nadu, India, 2 510(k) clearances
Tekna Manufacturing Pvt. Ltd. is registered with the FDA (registration 3013595329) in Chennai Tamil Nadu, India. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 6, 2000. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013595329
- Address
- C19, Industrial Estate, Guindy, Chennai Tamil Nadu, India, 600032
- Owner or operator
- Tekna Manufacturing Pvt. Ltd (10045541)
- Roles
- Manufacturer
- First device listed
- November 27, 2013
- Registered through
- 2026
- Brand names listed
- Hybrid 3200 Series Monoplace Hyperbaric Chamber, Model 5000/XX Series Multiplace Hyperbaric Chamber;, Modular Multiplace Hyperbaric Chamber, Ultrabaric oxygen treatment hood
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Chamber, Hyperbaric | CBF | 2 | Manufacturer | accessdata.fda.gov |
| Hood, Oxygen, Infant | FOG | 1 | 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 |
|---|---|---|---|---|---|---|
| December 6, 2000 | K002795 | MODEL HYBRID 3200 MONOPLACE, HYPERBARIC THERAPY SYSTEMS | CBF | Substantially Equivalent | Hypertec, Inc. | accessdata.fda.gov |
| December 6, 2000 | K002794 | MODEL 5000 MULTIPLACE HYPERBARIC THERAPY | CBF | Substantially Equivalent | Hypertec, Inc. | accessdata.fda.gov |
Compare with other makers
Updated December 6, 2000. 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.