K862536

Substantially Equivalent

MODEL 1010 AMBULATORY PH MONITORING SYSTEM

Applicant: Oxford Medilog, Inc.
Product code: FFT
Advisory panel: Gastroenterology, Urology
Date received: 1986-07-02
Decision date: 1986-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clearwater, FL, US

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.