FDA 510(k) K002028, BRAVO PH MONITORING SYSTEM, by Endonetics, Inc.
FDA 510(k) K002028, BRAVO PH MONITORING SYSTEM, by Endonetics, Inc.
Device Classification Name: Electrode, Ph, Stomach
510(k) Number: K002028
Device Name: BRAVO PH MONITORING SYSTEM
Applicant: Endonetics, Inc.
Regulation Number: 876.1400
Classification Product Code: FFT
Date Received: 07/03/2000
Decision Date: 09/29/2000
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
510k Review Panel: Gastroenterology/Urology
Total number of pages: 532
Fully redacted pages: 329
Content pages: 203
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