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510(k) K003763

2010 PLUS HOLTER FOR WINDOWS by Agilent Technologies — Product Code MLO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 2001
Date Received
December 6, 2000
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph, Ambulatory, With Analysis Algorithm
Device Class
Class II
Regulation Number
870.2800
Review Panel
CV
Submission Type

Other clearances by Agilent Technologies

  • K163367 — GenetiSure Dx Postnatal Assay (August 11, 2017)
  • K010949 — 2010 PLUS HOLTER FOR WINDOWS (September 28, 2001)
  • K012094 — MODIFICATION TO DEVICE LINK SYSTEM, MODEL M2376A (July 20, 2001)
  • K011824 — AGILENT M2636B TELEMON B MONITOR (TELEMON B) (July 2, 2001)
  • 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)

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  • K193177 — CER-S (August 26, 2020)
  • K182030 — Faros Mobile (November 8, 2018)
  • K140847 — CARDIOSPY ECG HOLTER SYSTEMS (December 5, 2014)
  • K131897 — CV3000 HOLTER ANALYSIS SYSTEM (November 26, 2013)
  • K130660 — AUDICOR CPAM WITH SDB (SINGLE SENSOR) (October 11, 2013)
  • K120462 — AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED (September 20, 2012)
  • K111487 — NH-301 AMBULATORY ECG ANALYSIS SOFTWARE (November 10, 2011)