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510(k) K964589

FLEXILOG 3000 by Oakfield Instruments, Ltd. — Product Code KLA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1997
Date Received
November 15, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Esophageal Motility, Anorectal Motility, And Tube
Device Class
Class II
Regulation Number
876.1725
Review Panel
GU
Submission Type

Other clearances by Oakfield Instruments, Ltd.

  • K964804 — FLEXILOG LS (August 6, 1997)
  • K961895 — FLEXILOG LS 13921 (November 4, 1996)
  • K945069 — FLEXILOG 2000 (June 13, 1995)
  • K920115 — MEDISCINT (March 30, 1992)
  • K902460 — CARDIOSCINT (LEFT VENTRICULAR FUNCTION MONITOR) (August 28, 1990)
  • K896288 — FLEXILOG 1010 AMBULATORY PH MONITORING SYSTEM (May 4, 1990)
  • K894902 — SOURCERER (October 17, 1989)

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  • K031617 — MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETER (January 16, 2004)
  • K032138 — MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC SINGLE USE ANOREC (October 9, 2003)