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510(k) K051759

FLEXI-LITE, MODEL FL-V1.2 by Performance Hyperbarics — Product Code CBF

K051759 is an FDA 510(k) premarket notification submitted by Performance Hyperbarics for the device "FLEXI-LITE, MODEL FL-V1.2". The FDA issued a decision of Substantially Equivalent on November 17, 2005. 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
November 17, 2005
Date Received
June 29, 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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  • K092991 — O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING) (August 13, 2010)
  • K101262 — FLEXI-LITE (June 10, 2010)
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FDA data resources