DECONTAMINATING MACHINES, LS-850, LS-76, DW/T-216, T-21— 510(k) K911120

Substantially Equivalent

Hamo USA, Inc.

FDA 510(k) clearance K911120 for DECONTAMINATING MACHINES, LS-850, LS-76, DW/T-216, T-21, Substantially Equivalent on 1994-02-03. Applicant: Hamo USA, Inc..

Clearance details

Applicant: Hamo USA, Inc.
Product code: Code MEC
Advisory panel: General Hospital
Date received: 1991-03-11
Decision date: 1994-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

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Adverse events under product code MEC

product code MEC

Malfunction: 483
Other: 1
Total: 484

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.