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510(k) K902366

MODIFIED PROXIMA MONITOR/DIGITRAPPER ED UNIT by Synectics-Dantec — Product Code FFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 1990
Date Received
May 16, 1990
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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