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510(k) K911761

SYSTEM ATHENA, TYPE 9266 SA02, MODIFICATION by S & W Medico Teknik — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1991
Date Received
March 22, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter
Device Class
Class II
Regulation Number
870.2700
Review Panel
AN
Submission Type

Other clearances by S & W Medico Teknik

  • K964593 — DIASCOPE TRAVELLER PLUS (4053) (June 30, 1997)
  • K940933 — 9267 SPO2 ATHENA MODULE (November 29, 1995)
  • K942196 — 3050 DIASCOPE NT PATIENT MONITOR (June 28, 1995)
  • 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)

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