TALL FLOOR STAND TFS-01— 510(k) K831939

Name: FDA 510(k) clearance K831939
Creator: U.S. Food and Drug Administration
Published: 1983-07-19

Substantially Equivalent

Sorensen Research

FDA 510(k) clearance K831939 for TALL FLOOR STAND TFS-01, Substantially Equivalent on 1983-07-19. Applicant: Sorensen Research. Device class: 2.

Clearance details

Applicant: Sorensen Research
Product code: Code GCX
Device class: Class 2
Regulation: 21 CFR 880.6740
Advisory panel: General Hospital
Date received: 1983-06-16
Decision date: 1983-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K833094 — TRANSDUCER DOME SD1041983-11-03
K833095 — TRANSDUCER DOME SD1051983-11-03
K833096 — TRANSDUCER DOME DS1061983-11-03

Adverse events under product code GCX

product code GCX

Death: 9
Malfunction: 592
Other: 2
Total: 603

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.