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510(k) K053498

HYPEROX 101 by Wjo, Inc. — Product Code CBF

K053498 is an FDA 510(k) premarket notification submitted by Wjo, Inc. for the device "HYPEROX 101". The FDA issued a decision of Substantially Equivalent on March 15, 2006. The device falls under product code CBF (Chamber, Hyperbaric), a Class II device regulated under 21 CFR 868.5470.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 2006
Date Received
December 16, 2005
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

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FDA data resources