The following data is part of a premarket notification filed by Endonetics, Inc. with the FDA for Bravo Ph Monitoring System.
| Device ID | K002028 | 
| 510k Number | K002028 | 
| Device Name: | BRAVO PH MONITORING SYSTEM | 
| Classification | Electrode, Ph, Stomach | 
| Applicant | ENDONETICS, INC. 987 UNIVERSITY AVE.;STE. 14 Los Gatos, CA 95032 | 
| Contact | William A Knape | 
| Correspondent | William A Knape ENDONETICS, INC. 987 UNIVERSITY AVE.;STE. 14 Los Gatos, CA 95032 | 
| Product Code | FFT | 
| CFR Regulation Number | 876.1400 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 2000-07-03 | 
| Decision Date | 2000-09-29 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  BRAVO PH MONITORING SYSTEM  76051073  not registered Dead/Abandoned | MEDTRONIC ENDONETICS, INC. 2000-05-18 |