ISO-THERMEX— 510(k) K861100

Substantially Equivalent

Columbus Instruments Intl. Corp.

FDA 510(k) clearance K861100 for ISO-THERMEX, Substantially Equivalent on 1986-05-12. Applicant: Columbus Instruments Intl. Corp..

Clearance details

Applicant: Columbus Instruments Intl. Corp.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 1986-03-24
Decision date: 1986-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbus, OH, US

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Adverse events under product code FLL

product code FLL

Death: 3
Malfunction: 557
Total: 560

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.