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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 the device name listed in this FDA 510(k) record. The listed applicant is Mac Medical, Inc.. It received FDA 510(k) clearance on 2019-03-05 under 510(k) 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. The listed applicant is Mac Medical, Inc.. The 510(k) number is K180842.

When did MAC Medical D-Series Blanket and Solution Warming Cabinets receive FDA 510(k) clearance?

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

Who is the listed applicant for MAC Medical D-Series Blanket and Solution Warming Cabinets?

The FDA 510(k) record lists Mac Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Devices (Code: LGZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260988°M Warmer System with °M StationMequ A/SK252636Fluido Compact SystemThe Surgical Company International B.V.K251733Fluido® AirGuard SystemThe Surgical Company International BV (As Tsc Life)K232107°M Warmer SystemMequ A/SK211618Fluido Compact Blood and Fluid Warming SystemThe Surgical Company International B.V.K211800Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid WarmerQuality IN Flow , Ltd.

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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