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510(k) K934753

STAR BREATHING CIRCUITS by Infrasonics Corp. — Product Code BZO

K934753 is an FDA 510(k) premarket notification submitted by Infrasonics Corp. for the device "STAR BREATHING CIRCUITS". The FDA issued a decision of Substantially Equivalent on October 27, 1993. The device falls under product code BZO (Set, Tubing And Support, Ventilator (W Harness)), a Class I device regulated under 21 CFR 868.5975. Infrasonics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1993
Date Received
October 4, 1993
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)
  • 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)
  • K896825 — TRANSCUTANEOUS ELECTRONIC NERVE STIMULATOR (November 16, 1990)

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