MAC Medical D-Series Blanket and Solution Warming Cabinets— 510(k) K180842

Name: FDA 510(k) clearance K180842
Creator: U.S. Food and Drug Administration
Published: 2019-03-05

Substantially Equivalent

Mac Medical, Inc.

FDA 510(k) clearance K180842 for MAC Medical D-Series Blanket and Solution Warming Cabinets, Substantially Equivalent on 2019-03-05. Applicant: Mac Medical, Inc.. Device class: 2.

Clearance details

Applicant: Mac Medical, Inc.
Product code: Code LGZ
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 2018-03-30
Decision date: 2019-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Millstadt, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LGZ

product code LGZ

Death: 16
Malfunction: 5,916
Other: 1
Total: 5,933

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.