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510(k) K943106

ADULT VENTILATOR by Infrasonics Corp. — Product Code CBK

Clearance Details

Decision
ST ()
Decision Date
December 28, 1995
Date Received
June 29, 1994
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.

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  • 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)
  • K896825 — TRANSCUTANEOUS ELECTRONIC NERVE STIMULATOR (November 16, 1990)

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