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510(k) K012094

MODIFICATION TO DEVICE LINK SYSTEM, MODEL M2376A by Agilent Technologies, Inc. — Product Code MWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 2001
Date Received
July 5, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type

Other clearances by Agilent Technologies, Inc.

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  • K010634 — HEARTSTREAM XL DEFIBIBRILLATOR/MONITOR, MODEL M4735A, HEARTSTREAM XLT DEFIBRILLA (June 11, 2001)
  • K011578 — M2376A DEVICELINK SYSTEM, MODEL M2376A (June 8, 2001)
  • K003819 — HEARTSTREAM ATTENUATED DEFIBRILLATION PADS, MODEL M3870A (May 2, 2001)
  • K011093 — AGILENT INFORMATION CENTER SOFTWARE FOR M3150,M3151,M3153 AND M3154 (May 1, 2001)
  • K010453 — M2376A DEVICELINK SYSTEM (March 2, 2001)
  • K010342 — M2376A DEVICELINK SYSTEM, MODEL M2376A (February 14, 2001)
  • K003940 — 2010 PLUS HOLTER FOR WINDOWS (February 8, 2001)

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