FDA 510(k)

SONIK MONARK 100

K-번호: K234036 · 2024-02-15

결정일2024-02-15

제품 코드LXM

결정Substantially Equivalent

기기 요약

SONIK MONARK 100 is the device name listed in this FDA 510(k) record. The listed applicant is Neuro Spinal Innovation, Inc.. It received FDA 510(k) clearance on 2024-02-15 under 510(k) number K234036. The device is classified under product code LXM. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the SONIK MONARK 100?

SONIK MONARK 100 is a medical device that received FDA 510(k) clearance on 2024-02-15. The listed applicant is Neuro Spinal Innovation, Inc.. The 510(k) number is K234036.

When did SONIK MONARK 100 receive FDA 510(k) clearance?

SONIK MONARK 100 received FDA 510(k) clearance on 2024-02-15, under 510(k) number K234036.

Who is the listed applicant for SONIK MONARK 100?

The FDA 510(k) record lists Neuro Spinal Innovation, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SONIK MONARK 100?

The FDA product code for SONIK MONARK 100 is LXM.

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SONIK MONARK 100

기기 요약

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관련 임상시험

관련 기기 (코드: LXM)

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