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510(k) K972158

GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES by Princeton Regulatory Assoc. — Product Code MEB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 1998
Date Received
June 9, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Princeton Regulatory Assoc.

  • K965136 — UROSURGE UROTHERM FLUID WARMING SYSTEM (October 16, 1998)
  • K973504 — UROSURGE UROSTENT (January 30, 1998)
  • K962770 — UROSURGE ACUTRAINER (August 1, 1996)

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  • K181360 — ON-Q* Pump with Bolus (March 22, 2019)
  • K151650 — SMARTez elastomeric infusion pump (April 4, 2016)
  • K131249 — ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES (February 3, 2014)
  • K131247 — MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM (August 14, 2013)
  • K090300 — MODIFICATION TO AUTOFUSER (April 30, 2009)
  • K081905 — ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP (July 15, 2008)
  • K071532 — ALPHA INFUSION PUMP, MODEL A200, A450 (February 19, 2008)
  • K072921 — DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM (November 26, 2007)