THERMAL PROBE COVER— 510(k) K915831

Substantially Equivalent

Vermont Medical, Inc.

FDA 510(k) clearance K915831 for THERMAL PROBE COVER, Substantially Equivalent on 1992-06-08. Applicant: Vermont Medical, Inc..

Clearance details

Applicant: Vermont Medical, Inc.
Product code: Code FMT
Advisory panel: General Hospital
Date received: 1991-12-30
Decision date: 1992-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bellows Falls, VT, US

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Adverse events under product code FMT

product code FMT

Death: 4
Malfunction: 3,074
Total: 3,078

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.