PROXIMA 1 PH MONITOR— 510(k) K841384

Name: FDA 510(k) clearance K841384
Creator: U.S. Food and Drug Administration
Published: 1984-07-19

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.. Device class: 1.

Clearance details

Applicant: American Endoscopy, Inc.
Product code: Code FFT
Device class: Class 1
Regulation: 21 CFR 876.1400
Advisory panel: Gastroenterology, Urology
Date received: 1984-03-20
Decision date: 1984-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from American Endoscopy, Inc.

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K853274 — AMERICAN DILATATION SYSTEM1985-10-17
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K833859 — TAMPONADE BALLOON CUFF1984-01-03
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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.