Home / 510(k) Clearances / K011565

510(k) K011565

INFANT OXYGEN TREATMENT HOOD by Gulf Coast Hyperbarics, Inc. — Product Code CBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2001
Date Received
May 21, 2001
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 by Gulf Coast Hyperbarics, Inc.

  • K082455 — RECTANGULAR MULTIPLACE HYPERBARIC CHAMBER (May 22, 2009)
  • K950957 — MULTIPLACE HYPERBARIC TREATMENT CHAMBER SYSTEM (June 2, 1995)

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)
  • K171899 — Revitalair 430F (November 22, 2019)
  • 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)