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510(k) K840865

INFANT STAR VENTILATOR by Infrasonics Corp. — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 1984
Date Received
February 27, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Continuous, Facility Use
Device Class
Class II
Regulation Number
868.5895
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)

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