BRAVO PH MONITORING SYSTEM


information about

Device Classification Name

electrode, ph, stomach

510(k) Number K002028
Device Name BRAVO PH MONITORING SYSTEM
Original Applicant
ENDONETICS, INC.
987 university ave.;ste. 14
los gatos, 
CA 
95032

Original Contact william a knape
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

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls