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510(k) K993907

VIRIDIA INFORMATION CENTER SOFTWARE FOR M3154A OPT C22 by Agilent Technologies, Inc. — Product Code MHD

K993907 is an FDA 510(k) premarket notification submitted by Agilent Technologies, Inc. for the device "VIRIDIA INFORMATION CENTER SOFTWARE FOR M3154A OPT C22". The FDA issued a decision of Substantially Equivalent on December 6, 1999. The device falls under product code MHD (Pump, Infusion, Gallstone Dissolution), a Class II device regulated under 21 CFR 880.5725. Agilent Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 1999
Date Received
November 17, 1999
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion, Gallstone Dissolution
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

Other clearances by Agilent Technologies, Inc.

  • 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)

FDA data resources