Home / 510(k) Clearances / K171899

510(k) K171899

Revitalair 430F by Oxavita Srl — Product Code CBF

K171899 is an FDA 510(k) premarket notification submitted by Oxavita Srl for the device "Revitalair 430F". The FDA issued a decision of Substantially Equivalent on November 22, 2019. 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 22, 2019
Date Received
June 26, 2017
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

Other clearances for product code CBF

  • K240569 — FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber (November 21, 2024)
  • K220290 — Revitalair 430+ (May 4, 2023)
  • K163109 — OxyHeal 4000 Multiplace Hyperbaric Chamber Family (March 22, 2017)
  • K152223 — Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen (April 29, 2016)
  • K140559 — SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER (May 30, 2014)
  • K102831 — RSI 4200 (August 19, 2011)
  • K092991 — O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING) (August 13, 2010)
  • K101262 — FLEXI-LITE (June 10, 2010)
  • K100268 — SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER (April 26, 2010)
  • K082455 — RECTANGULAR MULTIPLACE HYPERBARIC CHAMBER (May 22, 2009)

FDA data resources