510(k) K002028 ยท FFT Electrode, Ph, Stomach
BRAVO PH MONITORING SYSTEM
| Applicant | Endonetics, Inc., Los Gatos CA, US |
| Decision | Substantially Equivalent, Sep 29, 2000 |
| Received | Jul 3, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002028
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 6, 2016 | Covidien LLC Given Imaging Bravo pH capsule delivery device, 5-pack.
In-Vitro Diagnostic for pH monitoring of gastric reflux
Item Number: FGS-0312
The Bravo pH Monitoring System is intended to be used for gastroe Terminated |
FFT | None listed |
| May 6, 2016 | Covidien LLC Given Imaging Bravo pH capsule delivery device, 1-pack.
In- Vitor Diagnostic for pH monitoring of gastric reflux
Item Number: FGS-0313
The Bravo pH Monitoring System is intended to be used for gastro Terminated |
FFT | None listed |
| May 7, 2008 | Medtronic Neuromodulation Medtronic Bravo pH Capsule with Delivery System, Stomach pH electrode, Product Numbers 9012B1011 and 9012B1001. Medtronic, Inc., Minneapolis, MN 55432 Terminated |
FFT | None listed |
| Jul 20, 2004 | Medtronic Gastroenterology / Urology Bravo pH Monitoring System Receiver Terminated |
FGM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.