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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