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510(k) K833459

COAXIAL VOL. VENTILATOR CIRCUIT by Airco/Ohio Medical Products — Product Code BZO

K833459 is an FDA 510(k) premarket notification submitted by Airco/Ohio Medical Products for the device "COAXIAL VOL. VENTILATOR CIRCUIT". The FDA issued a decision of Substantially Equivalent on January 10, 1984. The device falls under product code BZO (Set, Tubing And Support, Ventilator (W Harness)), a Class I device regulated under 21 CFR 868.5975. Airco/Ohio Medical Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 1984
Date Received
October 5, 1983
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 Airco/Ohio Medical Products

  • K833452 — OHIO GMS ABSORBER (November 29, 1983)
  • K832418 — OHIO TEMPERATURE SIMULATOR (September 12, 1983)
  • K832565 — OHIO 5400 VOLUME MONITOR (September 1, 1983)
  • K832185 — OHIO MODEL 922 SPIROMETER (August 12, 1983)
  • K830446 — OXYGEN MONITOR OHIO 5100 (March 24, 1983)
  • K822456 — OHIO V5A ANESTHESIA VENTILATOR (September 21, 1982)
  • K813476 — OHIO VOLUME INCENTIVE SPIROMETER (December 31, 1981)
  • K812880 — OHIO NON-REUSABLE TRACHEAL TUBE MAJILL (November 24, 1981)
  • K812879 — OHIO NON-REUSABLE TRACHEAL TUBE MURPHY (November 24, 1981)
  • K811413 — DABC NONCONDUCTIVE PEDIAT. ANESTH. CIR (June 2, 1981)

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