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510(k) K081506

HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS by Hyperbaric America, LLC — Product Code CBF

K081506 is an FDA 510(k) premarket notification submitted by Hyperbaric America, LLC for the device "HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS". The FDA issued a decision of Substantially Equivalent on July 25, 2008. 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
July 25, 2008
Date Received
May 29, 2008
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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FDA data resources