TRANS 2000— 510(k) K771018

Substantially Equivalent

Hamilton Industries, Inc.

FDA 510(k) clearance K771018 for TRANS 2000, Substantially Equivalent on 1977-07-14. Applicant: Hamilton Industries, Inc..

Clearance details

Applicant: Hamilton Industries, Inc.
Product code: Code INK
Advisory panel: Physical Medicine
Date received: 1977-06-06
Decision date: 1977-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code INK

product code INK

Malfunction: 708
Other: 1
Total: 709

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.