FDA 510(k)

Navigator (FMNVG15); Navigator XL (FMNVX06)

K-번호: K240105 · 2024-08-29

결정일2024-08-29

제품 코드ITI

자문 위원회PM

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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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Navigator (FMNVG15); Navigator XL (FMNVX06)

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: ITI)

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