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Certifications

At Fink Engineering, our commitment to excellence is reflected in our robust Quality Management System.
We adhere to the highest international standards, ensuring the safety, reliability, and superior performance of all our products and services.

  • Built to ASME-PVHO-1 and NFPA 99 standards, each unit has been inspected and appropriately stamped
  • FDA-approved 510 (K), and Australian Therapeutic Goods Administration (TGA) medical device, air-compressed chambers
  • Designed and built using ISO 13485 (medical device) and 9001 general quality standards
  • Products recently certified to new FDA standards including biocompatibility, Electrical Interference (EMI) and cyber-security
  • Delivering 100% oxygen at up to 2 ATA via personalized mask
  • Class-II Medical-Device requiring a prescription from a licensed physician
  • All our chambers are approved for clinic or home use

FDA 510 (K)

ISO 9001:2015

Certificate No: QEC21469

ISO 13485:2016

Certificate No: CERT-0126250

ASME

PVHO-1

ARTG No: 182494

Multiplace hyperbaric chambers

ARTG No: 148448 & 147769

Sechrist Monoplace hyperbaric chambers and Stretcher

Registered Establishment No: 3006097795

For rectangular hyperbaric facilities

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Email: info@fink.com.au

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