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510(k) K896288

FLEXILOG 1010 AMBULATORY PH MONITORING SYSTEM by Oakfield Instruments, Ltd. — Product Code FFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 1990
Date Received
October 30, 1989
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)
  • K894902 — SOURCERER (October 17, 1989)

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  • K925405 — ZINETICS COMPOSITE SENSOR PROBE W/INTERNAL REF. (September 30, 1994)