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510(k) K152223

Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System by Oxyheal Medical Systems, Inc. — Product Code CBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2016
Date Received
August 7, 2015
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 Oxyheal Medical Systems, Inc.

  • K163109 — OxyHeal 4000 Multiplace Hyperbaric Chamber Family (March 22, 2017)

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  • K101262 — FLEXI-LITE (June 10, 2010)
  • K100268 — SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER (April 26, 2010)
  • K082455 — RECTANGULAR MULTIPLACE HYPERBARIC CHAMBER (May 22, 2009)