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510(k) K052866

OXYHEAL 1000 MONOPLACE HYPERBARIC CHAMBER by Oxyheal Health Group — Product Code CBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2005
Date Received
October 11, 2005
Clearance Type
Abbreviated
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

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