FDA 510(k)

MiiS Horus Scope DPT 100

Número K: K181260 · 2019-06-21

RequerenteMedimaging Integrated Solution, Inc (Miis)

Data da decisão2019-06-21

Código do produtoHKX

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

MiiS Horus Scope DPT 100 is the device name listed in this FDA 510(k) record. The listed applicant is Medimaging Integrated Solution, Inc (Miis). It received FDA 510(k) clearance on 2019-06-21 under 510(k) number K181260. The device is classified under product code HKX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MiiS Horus Scope DPT 100?

MiiS Horus Scope DPT 100 is a medical device that received FDA 510(k) clearance on 2019-06-21. The listed applicant is Medimaging Integrated Solution, Inc (Miis). The 510(k) number is K181260.

When did MiiS Horus Scope DPT 100 receive FDA 510(k) clearance?

MiiS Horus Scope DPT 100 received FDA 510(k) clearance on 2019-06-21, under 510(k) number K181260.

Who is the listed applicant for MiiS Horus Scope DPT 100?

The FDA 510(k) record lists Medimaging Integrated Solution, Inc (Miis) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MiiS Horus Scope DPT 100?

The FDA product code for MiiS Horus Scope DPT 100 is HKX.

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Outros registros que listam Medimaging Integrated Solution, Inc (Miis) como candidato(a)

K253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)K234113MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box K223926VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box K214050ENT Nasopharyngoscope and Accessories K193188MiiS Horus Eye Anterior Camera K170470Digital Eye Anterior Camera

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