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510(k) K911804

INFRASONICS VENTILATOR ADULT STAR, MODIFICATION by Infrasonics Corp. — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 1992
Date Received
April 24, 1991
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)
  • K913972 — STAR SYNC, MODIFICATION (January 9, 1992)
  • K905272 — ADULT STAR, MODIFICATION (January 30, 1991)
  • K896825 — TRANSCUTANEOUS ELECTRONIC NERVE STIMULATOR (November 16, 1990)

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