AMBI-24 PH/PRESSURE MONITOR— 510(k) K854514

Substantially Equivalent

Biosearch Medical Products, Inc.

FDA 510(k) clearance K854514 for AMBI-24 PH/PRESSURE MONITOR, Substantially Equivalent on 1986-02-24. Applicant: Biosearch Medical Products, Inc..

Clearance details

Applicant: Biosearch Medical Products, Inc.
Product code: Code FFT
Advisory panel: Gastroenterology, Urology
Date received: 1985-11-12
Decision date: 1986-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerville, NJ, US

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.