FDA 510(k)

HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch)

Número K: K213655 · 2023-01-17

Data da decisão2023-01-17

Código do produtoIPF

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch) is the device name listed in this FDA 510(k) record. The listed applicant is Hilltek, LLC. It received FDA 510(k) clearance on 2023-01-17 under 510(k) number K213655. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch)?

HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch) is a medical device that received FDA 510(k) clearance on 2023-01-17. The listed applicant is Hilltek, LLC. The 510(k) number is K213655.

When did HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch) receive FDA 510(k) clearance?

HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch) received FDA 510(k) clearance on 2023-01-17, under 510(k) number K213655.

Who is the listed applicant for HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch)?

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

What is the FDA product code for HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch)?

The FDA product code for HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch) is IPF.

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