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510(k) K101262

FLEXI-LITE by Pressure-Tech, Inc. — Product Code CBF

K101262 is an FDA 510(k) premarket notification submitted by Pressure-Tech, Inc. for the device "FLEXI-LITE". The FDA issued a decision of Substantially Equivalent on June 10, 2010. 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
June 10, 2010
Date Received
May 5, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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