FDA 510(k)

MAC Medical D-Series Blanket and Solution Warming Cabinets

Номер K: K180842 · 2019-03-05

Дата решения2019-03-05

Код продуктаLGZ

Консультативный комитетHO

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Связанные устройства (Код: LGZ)

K262532NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61)ICU Medical K260988°M Warmer System with °M StationMequ A/S K252636Fluido Compact SystemThe Surgical Company International B.V.K251733Fluido® AirGuard SystemThe Surgical Company International BV (As Tsc Life)K232107°M Warmer SystemMequ A/S K211618Fluido Compact Blood and Fluid Warming SystemThe Surgical Company International B.V.

Официальный источник

Посмотреть в базе данных FDA →

Данные получены из открытого API FDA. Для получения наиболее актуальной и авторитетной информации всегда обращайтесь к официальным записям.