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510(k) K895853

SECHRIST DISPOSABLE INFANT BREATHING CIRCUIT by Sechrist Industries, Inc. — Product Code BZO

K895853 is an FDA 510(k) premarket notification submitted by Sechrist Industries, Inc. for the device "SECHRIST DISPOSABLE INFANT BREATHING CIRCUIT". The FDA issued a decision of Substantially Equivalent on December 22, 1989. The device falls under product code BZO (Set, Tubing And Support, Ventilator (W Harness)), a Class I device regulated under 21 CFR 868.5975. Sechrist Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1989
Date Received
October 3, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Tubing And Support, Ventilator (W Harness)
Device Class
Class I
Regulation Number
868.5975
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)
  • K052713 — MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER (October 28, 2005)
  • 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)

Other clearances for product code BZO

  • K953784 — UNICOR, INC. CORRUGATED TUBING (September 19, 1995)
  • K953785 — UNICOR, INC. VENTILATOR HOSES (September 18, 1995)
  • K952011 — PRIMA BREATHING BAGS (May 22, 1995)
  • K952022 — PRIMA VOLUMN VENTILATORSS (May 22, 1995)
  • K952010 — PRIMA VENTILATOR HOSES (May 22, 1995)
  • K952012 — PRIMA CUSTOM ANESTESIA CIRCUIT (May 22, 1995)
  • K945740 — INFANT FLOW SYSTEM (March 23, 1995)
  • K944531 — PRIMA, INC. CORRUGATED TUBING (December 2, 1994)
  • K942572 — VOLUME VENTILATOR (June 10, 1994)
  • K942569 — VENTILATOR HOSE (June 10, 1994)

FDA data resources