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FDA 510(k)

MAC Medical D-Series Blanket and Solution Warming Cabinets

K-Number: K180842 · 2019-03-05

ApplicantMac Medical, Inc.
Decision Date2019-03-05
Product CodeLGZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MAC Medical D-Series Blanket and Solution Warming Cabinets is a medical device manufactured by Mac Medical, Inc.. It received FDA 510(k) clearance on 2019-03-05 under approval number K180842. The device is classified under product code LGZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAC Medical D-Series Blanket and Solution Warming Cabinets?

MAC Medical D-Series Blanket and Solution Warming Cabinets is a medical device that received FDA 510(k) clearance on 2019-03-05. It is manufactured by Mac Medical, Inc.. The 510(k) number is K180842.

When was MAC Medical D-Series Blanket and Solution Warming Cabinets approved by the FDA?

MAC Medical D-Series Blanket and Solution Warming Cabinets received FDA 510(k) clearance on 2019-03-05, under approval number K180842.

What company makes MAC Medical D-Series Blanket and Solution Warming Cabinets?

MAC Medical D-Series Blanket and Solution Warming Cabinets is manufactured by Mac Medical, Inc..

What is the FDA product code for MAC Medical D-Series Blanket and Solution Warming Cabinets?

The FDA product code for MAC Medical D-Series Blanket and Solution Warming Cabinets is LGZ.

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Related PubMed Literature

PMID: 39396094 A scoping review on advancements in noninvasive wearable technology for heart failure management. NPJ digital medicine (2024) PMID: 37008598 Characteristics of pivotal clinical trials of FDA-approved endovascular devices between 2000 and 2018: An interrupted time series analysis. Journal of clinical and translational science (2023) PMID: 36584081 Stakeholder perspectives on scaling up medical device reprocessing: A qualitative study. PloS one (2022) PMID: 29080388 Review and approval of medical devices in China: Changes and reform. Journal of biomedical materials research. Part B, Applied biomaterials (2018)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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