FDA 510(k)

STIMPOD NMS450 Nerve Stimulator

K-번호: K213049 · 2022-10-16

결정일2022-10-16

제품 코드BXN

자문 위원회안내: 의료기기 규제 문서 번역 요청입니다. 회사명, 제품명, FDA, 510(k), PMA, NCT, PMID, 식별자 및 URL을 보존하여 번역하여 주세요. 정책: 의료규제-v1. [원문] AN [번역] 안내

결정Substantially Equivalent

기기 요약

STIMPOD NMS450 Nerve Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Xavant Technology (Pty), Ltd.. It received FDA 510(k) clearance on 2022-10-16 under 510(k) number K213049. The device is classified under product code BXN. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the STIMPOD NMS450 Nerve Stimulator?

STIMPOD NMS450 Nerve Stimulator is a medical device that received FDA 510(k) clearance on 2022-10-16. The listed applicant is Xavant Technology (Pty), Ltd.. The 510(k) number is K213049.

When did STIMPOD NMS450 Nerve Stimulator receive FDA 510(k) clearance?

STIMPOD NMS450 Nerve Stimulator received FDA 510(k) clearance on 2022-10-16, under 510(k) number K213049.

Who is the listed applicant for STIMPOD NMS450 Nerve Stimulator?

The FDA 510(k) record lists Xavant Technology (Pty), Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STIMPOD NMS450 Nerve Stimulator?

The FDA product code for STIMPOD NMS450 Nerve Stimulator is BXN.

Xavant Technology (Pty), Ltd.를 신청인으로 등재한 기타 기록

K161091STIMPOD NMS460 Nerve Stimulator

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