FDA 510(k)

ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System

Номер K: K202461 · 2022-08-12

ЗаявительSmisson-Cartledge Biomedical, LLC

Дата решения2022-08-12

Код продуктаLGZ

Консультативный комитетHO

РешениеSubstantially Equivalent

Описание устройства

ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System is the device name listed in this FDA 510(k) record. The listed applicant is Smisson-Cartledge Biomedical, LLC. It received FDA 510(k) clearance on 2022-08-12 under 510(k) number K202461. 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 ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System?

ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System is a medical device that received FDA 510(k) clearance on 2022-08-12. The listed applicant is Smisson-Cartledge Biomedical, LLC. The 510(k) number is K202461.

When did ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System receive FDA 510(k) clearance?

ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System received FDA 510(k) clearance on 2022-08-12, under 510(k) number K202461.

Who is the listed applicant for ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System?

The FDA 510(k) record lists Smisson-Cartledge Biomedical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System?

The FDA product code for ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System 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.

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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

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