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510(k) K240569

FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber by Fink Engineering Pty, Ltd. — Product Code CBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2024
Date Received
February 29, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chamber, Hyperbaric
Device Class
Class II
Regulation Number
868.5470
Review Panel
AN
Submission Type

Other clearances by Fink Engineering Pty, Ltd.

  • K031649 — SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES (December 5, 2003)

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  • K152223 — Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen (April 29, 2016)
  • K140559 — SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER (May 30, 2014)
  • K102831 — RSI 4200 (August 19, 2011)
  • K092991 — O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING) (August 13, 2010)
  • K101262 — FLEXI-LITE (June 10, 2010)
  • K100268 — SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER (April 26, 2010)
  • K082455 — RECTANGULAR MULTIPLACE HYPERBARIC CHAMBER (May 22, 2009)