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510(k) K922314

VENTILATOR INTERFACE 9291/4 by S & W Medico Teknik — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1992
Date Received
May 18, 1992
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

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  • K923418 — 9293/1 INTERFACE MODULE (February 23, 1993)
  • K911611 — SYSTEM ATHENA, MODIFICATION (February 5, 1993)
  • K912815 — NIBP 9225 COMBI (October 9, 1992)

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