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510(k) K020974

BARA-MED ACRYLIC MONOPLACE HYPERBARIC CHAMBER by Environmental Tectonics Corp. — Product Code CBF

K020974 is an FDA 510(k) premarket notification submitted by Environmental Tectonics Corp. for the device "BARA-MED ACRYLIC MONOPLACE HYPERBARIC CHAMBER". The FDA issued a decision of SESU on June 26, 2002. The device falls under product code CBF (Chamber, Hyperbaric), a Class II device regulated under 21 CFR 868.5470. Environmental Tectonics Corp. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESU ()
Decision Date
June 26, 2002
Date Received
March 26, 2002
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 Environmental Tectonics Corp.

  • K092991 — O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING) (August 13, 2010)
  • K993010 — BARA-MED, ACRYLIC MONOPLACE HYPERBARIC CHAMBER (May 30, 2000)

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)

FDA data resources