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510(k) K955026

AS/3 NMT MODULE by Datex Medical Instrumentation, Inc. — Product Code KOI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 1997
Date Received
November 2, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve, Peripheral, Electric
Device Class
Class II
Regulation Number
868.2775
Review Panel
AN
Submission Type

Other clearances by Datex Medical Instrumentation, Inc.

  • K961063 — AS/3 CARDIAC OUTPUT & SVO2 MODULE (May 31, 1996)
  • 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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