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510(k) K964593

DIASCOPE TRAVELLER PLUS (4053) by S & W Medico Teknik A/S — Product Code DSI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 1997
Date Received
November 15, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Detector And Alarm, Arrhythmia
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

Other clearances by S & W Medico Teknik A/S

  • K940933 — 9267 SPO2 ATHENA MODULE (November 29, 1995)
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  • K913013 — TCPO2 9260 MODULE - SYSTEM ATHENA (May 3, 1994)
  • K934887 — 9750 ATHENA ETHERNET OPTION (January 14, 1994)
  • K915633 — MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENA (June 29, 1993)
  • K930134 — 9055 IRCA OPTION FOR SYSTEM ATHENA 9050 NT (April 9, 1993)
  • K923418 — 9293/1 INTERFACE MODULE (February 23, 1993)
  • K911611 — SYSTEM ATHENA, MODIFICATION (February 5, 1993)
  • K922314 — VENTILATOR INTERFACE 9291/4 (December 17, 1992)
  • K912815 — NIBP 9225 COMBI (October 9, 1992)

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