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510(k) K911611

SYSTEM ATHENA, MODIFICATION by S & W Medico Teknik — Product Code DRT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 1993
Date Received
April 9, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type

Other clearances by S & W Medico Teknik

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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)
  • K922314 — VENTILATOR INTERFACE 9291/4 (December 17, 1992)
  • K912815 — NIBP 9225 COMBI (October 9, 1992)

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