FDA 510(k), K031649, SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES

FDA 510(k), K031649, SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES

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510(K) Number: K031649
Device Name: SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES
Manufacturer: FINK ENGINEERING PTY LTD
Device Classification Name: Chamber, Hyperbaric
Regulation Number: 868.5470
Classification Product Code: CBF
Date Received: 05/28/2003
Decision Date: 12/05/2003
Regulation Medical Specialty: Anesthesiology
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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