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 |