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510(k) K072427

SIGMA SERIES HYPERBARIC CHAMBER by Perry Baromedical Corp. — Product Code CBF

K072427 is an FDA 510(k) premarket notification submitted by Perry Baromedical Corp. for the device "SIGMA SERIES HYPERBARIC CHAMBER". The FDA issued a decision of Substantially Equivalent on June 11, 2008. The device falls under product code CBF (Chamber, Hyperbaric), a Class II device regulated under 21 CFR 868.5470. Perry Baromedical Corp. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 2008
Date Received
August 29, 2007
Clearance Type
Abbreviated
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 Perry Baromedical Corp.

  • K990927 — SIGMA 3400 MONOPLACE HYPERBARIC CHAMBER (November 12, 1999)
  • K974868 — SIGMA PLUS MONOPLACE HYPERBARIC CHAMBER (July 2, 1998)

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