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510(k) K163109

OxyHeal 4000 Multiplace Hyperbaric Chamber Family by Oxyheal Medical Systems, Inc. — Product Code CBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2017
Date Received
November 7, 2016
Clearance Type
Special
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.

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