PROXIMA 1 PH MONITOR— 510(k) K841384

Substantially Equivalent

American Endoscopy, Inc.

FDA 510(k) clearance K841384 for PROXIMA 1 PH MONITOR, Substantially Equivalent on 1984-07-19. Applicant: American Endoscopy, Inc..

Clearance details

Applicant: American Endoscopy, Inc.
Product code: Code FFT
Advisory panel: Gastroenterology, Urology
Date received: 1984-03-20
Decision date: 1984-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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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.