Harvard 2 Syringe Pump

• • Terminated Z-0431-05 FDA Unclassified (pre-2012) ·initiated 3 Nov 2004

  Potential pump motor/encoder assembly failure may cause over infusing medication in patients

• • Terminated Z-1208-03 FDA Unclassified (pre-2012) ·initiated 11 Aug 2003

  Under specific sequence conditions, the unit may apper to be infusing, but is not

510(k) Number

K952794 ↗

FDA Product Code

FRN

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Model 2650 High Capacity Dual Syringe

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  FDA 510(k) K813644 Active Cleared 18 Feb 1982

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• The Harvard Library

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  FDA 510(k) K970678 Active Cleared 9 Jan 1998

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• Harvard/Lte Benchtop Steam Sterilizer (Autoclave)

  Class II

  FDA 510(k) K903613 Active Cleared 7 Nov 1990

• Syringe Infusion Pump #2716

  Class II

  FDA 510(k) K801904 Active Cleared 27 Aug 1980

See all devices from Harvard Apparatus, Inc. →