BRAVO PH MONITORING SYSTEM AND ACCESSORIES— 510(k) K102543

Substantially Equivalent

Given Imaging , Ltd.

FDA 510(k) clearance K102543 for BRAVO PH MONITORING SYSTEM AND ACCESSORIES, Substantially Equivalent on 2010-12-01. Applicant: Given Imaging , Ltd..

Clearance details

Applicant: Given Imaging , Ltd.
Product code: Code FFT
Advisory panel: Gastroenterology, Urology
Date received: 2010-09-03
Decision date: 2010-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yoqneam, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code FFT

product code FFT

Injury: 595
Malfunction: 2,175
Other: 1
Total: 2,771

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.