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510(k) K912815

NIBP 9225 COMBI by S & W Medico Teknik — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 1992
Date Received
June 6, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Device Class
Class II
Regulation Number
870.1130
Review Panel
CV
Submission Type

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  • K923418 — 9293/1 INTERFACE MODULE (February 23, 1993)
  • K911611 — SYSTEM ATHENA, MODIFICATION (February 5, 1993)
  • K922314 — VENTILATOR INTERFACE 9291/4 (December 17, 1992)

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