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510(k) K843036

PATIENT BREATHING CIRCUIT by Infrasonics Corp. — Product Code BZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 1984
Date Received
August 2, 1984
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 Infrasonics Corp.

  • K943106 — ADULT VENTILATOR (December 28, 1995)
  • K952878 — OXY/STAR LOW FLOW BLENDER (September 25, 1995)
  • K934753 — STAR BREATHING CIRCUITS (October 27, 1993)
  • K922654 — VENTILATOR ADULT STAR MODIFICATION (December 1, 1992)
  • K923704 — INFANT STAR SERIES 500 (October 22, 1992)
  • K922477 — MODEL 105 VENTILATOR, MODIFICATION (August 24, 1992)
  • K920954 — AIR STAR (August 3, 1992)
  • K911804 — INFRASONICS VENTILATOR ADULT STAR, MODIFICATION (June 11, 1992)
  • K913972 — STAR SYNC, MODIFICATION (January 9, 1992)
  • K905272 — ADULT STAR, MODIFICATION (January 30, 1991)

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)