TENET RADIOLUCENT HAND TABLE— 510(k) K963506

Name: FDA 510(k) clearance K963506
Creator: U.S. Food and Drug Administration
Published: 1997-01-09

Substantially Equivalent

Tenet Medical Engineering

FDA 510(k) clearance K963506 for TENET RADIOLUCENT HAND TABLE, Substantially Equivalent on 1997-01-09. Applicant: Tenet Medical Engineering. Device class: 1.

Clearance details

Applicant: Tenet Medical Engineering
Product code: Code FQO
Device class: Class 1
Regulation: 21 CFR 878.4960
Advisory panel: General, Plastic Surgery
Date received: 1996-09-03
Decision date: 1997-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Calgary, CA

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FQO

product code FQO

Death: 6
Injury: 145
Malfunction: 685
Total: 836

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.