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TEKNA Manufacturing Pvt. Ltd.
TEKNA MANUFACTURING PRIVATE LIMITED · Model Modular Multiplace Hyperbaric Chamber · UDI-DI 08906124944713
CBF
Prescription
1
510(k) clearances
153
Adverse events (12 deaths)
3
Recalls
18
Facilities
Description
Modular Multiplace Hyperbaric Chamber consisting of ASME 'U' Stamped pressure vessel that can accommodate 1 patients in the main lock and a control console for the same. The entire system is ASME PVHO-1 Compliant.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2014-08-08 | Baro-Therapies, Inc | The firm is distributing the Rejuvenator device without an approved 510(k). |
| 2008-08-28 | Sechrist Industries Inc | Sechrist conducted a field upgrade on the hyperbaulic chambers equipped with Electronic Control Modules in order to correct a software bug that could potentially affect the perform |
| 2008-08-28 | Sechrist Industries Inc | Sechrist conducted a field upgrade on the hyperbaulic chambers equipped with Electronic Control Modules in order to correct a software bug that could potentially affect the perform |
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