FDA 510(k)

Navigator (FMNVG15); Navigator XL (FMNVX06)

Número K: K240105 · 2024-08-29

Data da decisão2024-08-29

Código do produtoITI

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

Navigator (FMNVG15); Navigator XL (FMNVX06) is the device name listed in this FDA 510(k) record. The listed applicant is Forcemech International, LLC. It received FDA 510(k) clearance on 2024-08-29 under 510(k) number K240105. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Navigator (FMNVG15); Navigator XL (FMNVX06)?

Navigator (FMNVG15); Navigator XL (FMNVX06) is a medical device that received FDA 510(k) clearance on 2024-08-29. The listed applicant is Forcemech International, LLC. The 510(k) number is K240105.

When did Navigator (FMNVG15); Navigator XL (FMNVX06) receive FDA 510(k) clearance?

Navigator (FMNVG15); Navigator XL (FMNVX06) received FDA 510(k) clearance on 2024-08-29, under 510(k) number K240105.

Who is the listed applicant for Navigator (FMNVG15); Navigator XL (FMNVX06)?

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

What is the FDA product code for Navigator (FMNVG15); Navigator XL (FMNVX06)?

The FDA product code for Navigator (FMNVG15); Navigator XL (FMNVX06) is ITI.

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