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510(k) K903940

TYPE 9210 S/ECG by S & W Medico Teknik — Product Code DSI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1991
Date Received
August 27, 1990
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

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  • K915633 — MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENA (June 29, 1993)
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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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