PRESSURE MODULE 5M1247— 510(k) K771375

Name: FDA 510(k) clearance K771375
Creator: U.S. Food and Drug Administration
Published: 1977-09-15

Substantially Equivalent

Travenol Laboratories, S.A.

FDA 510(k) clearance K771375 for PRESSURE MODULE 5M1247, Substantially Equivalent on 1977-09-15. Applicant: Travenol Laboratories, S.A.. Device class: 2.

Clearance details

Applicant: Travenol Laboratories, S.A.
Product code: Code FKQ
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1977-07-25
Decision date: 1977-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FKQ

product code FKQ

Other: 1
Total: 1

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.