FOUR CHANNEL PH PROBE— 510(k) K853280

Substantially Equivalent

Akron City Hospital

FDA 510(k) clearance K853280 for FOUR CHANNEL PH PROBE, Substantially Equivalent on 1985-12-02. Applicant: Akron City Hospital.

Clearance details

Applicant: Akron City Hospital
Product code: Code FFT
Advisory panel: Gastroenterology, Urology
Date received: 1985-08-05
Decision date: 1985-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Akron, OH, 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.