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510(k) K023745

SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G by Sechrist Industries, Inc. — Product Code DTX

K023745 is an FDA 510(k) premarket notification submitted by Sechrist Industries, Inc. for the device "SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G". The FDA issued a decision of Substantially Equivalent on January 17, 2003. The device falls under product code DTX (Gas Control Unit, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4300. Sechrist Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2003
Date Received
November 7, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gas Control Unit, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4300
Review Panel
CV
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)
  • K052713 — MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER (October 28, 2005)
  • K993167 — MILLENNIUM INFANT VENTILATOR (November 10, 1999)
  • K992503 — SECHRIST AIR-OXYGEN MIXER, 3500/3500HL SERIES (August 10, 1999)
  • K950386 — MODEL 3200P/3200PR HYPERBARIC CHAMBER (June 13, 1995)
  • K934164 — MODEL 2500E/2500ER 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 DTX

  • K210669 — Quantum Mini Ventilation Module (May 4, 2021)
  • K202733 — Quantum Ventilation Module (October 16, 2020)
  • K181942 — Quantum Ventilation Module (October 18, 2018)
  • K101046 — STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM (December 9, 2010)
  • K965214 — COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002) (March 28, 1997)
  • K863902 — MODIFIED SARNS MEMBRANE OXYGENATOR (December 11, 1986)
  • K822820 — GAS-FLOW METER GFL 10 (October 18, 1982)
  • K792348 — STANICOR, OMNI-STAN,MOD 333B,334A GAMMA (December 5, 1979)
  • K790546 — FLOWMETER, OPTIFLO GAS (May 11, 1979)

FDA data resources