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510(k) K961063

AS/3 CARDIAC OUTPUT & SVO2 MODULE by Datex Medical Instrumentation, Inc. — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 1996
Date Received
March 18, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Programmable
Device Class
Class II
Regulation Number
870.1425
Review Panel
CV
Submission Type

Other clearances by Datex Medical Instrumentation, Inc.

  • K955026 — AS/3 NMT MODULE (April 28, 1997)
  • K960490 — AS/3 COMPACT AIRWAY MODULE M-CAIOV (May 3, 1996)
  • K953006 — AS/3 NETWORK LINK (September 27, 1995)
  • K912530 — CARDIOCAP II(TM) (September 5, 1991)

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