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510(k) K945069

FLEXILOG 2000 by Oakfield Instruments, Ltd. — Product Code FFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 1995
Date Received
October 14, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ph, Stomach
Device Class
Class I
Regulation Number
876.1400
Review Panel
GU
Submission Type

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  • 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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