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510(k) K052713

MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER by Sechrist Industries, Inc. — Product Code CBF

K052713 is an FDA 510(k) premarket notification submitted by Sechrist Industries, Inc. for the device "MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER". The FDA issued a decision of Substantially Equivalent on October 28, 2005. The device falls under product code CBF (Chamber, Hyperbaric), a Class II device regulated under 21 CFR 868.5470. Sechrist Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 2005
Date Received
September 29, 2005
Clearance Type
Special
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 Sechrist Industries, Inc.

  • K140559 — SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER (May 30, 2014)
  • K100268 — SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER (April 26, 2010)
  • K023745 — SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G (January 17, 2003)
  • K993167 — MILLENNIUM INFANT VENTILATOR (November 10, 1999)
  • K992503 — SECHRIST AIR-OXYGEN MIXER, 3500/3500HL SERIES (August 10, 1999)
  • K934164 — MODEL 2500E/2500ER HYPERBARIC CHAMBER (June 13, 1995)
  • K950386 — MODEL 3200P/3200PR HYPERBARIC CHAMBER (June 13, 1995)
  • K930713 — THE INFANT FLOW SYSTEM (September 16, 1993)
  • K914607 — SEHRIST VOLUME VENTILATOR, MODEL 2200B (November 2, 1992)
  • K896269 — SECHRIST VOLUME VENTILATOR MODEL 2200B (May 18, 1990)

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