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510(k) K002028

BRAVO PH MONITORING SYSTEM by Endonetics, Inc. — Product Code FFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2000
Date Received
July 3, 2000
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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