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510(k) K895853

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

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

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  • 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)
  • K952010 — PRIMA VENTILATOR HOSES (May 22, 1995)
  • K952022 — PRIMA VOLUMN VENTILATORSS (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)
  • K942569 — VENTILATOR HOSE (June 10, 1994)
  • K942572 — VOLUME VENTILATOR (June 10, 1994)