FDA 510(k)

SPECTRA 일회용 단루멘 에코성 주사 마취 전도針

K-번호: K151069 · 2016-02-05

결정일2016-02-05

제품 코드BSP

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

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기기 요약

SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle is the device name listed in this FDA 510(k) record. The listed applicant is Spectra Medical Devices, Inc.. It received FDA 510(k) clearance on 2016-02-05 under 510(k) number K151069. The device is classified under product code BSP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle?

SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle is a medical device that received FDA 510(k) clearance on 2016-02-05. The listed applicant is Spectra Medical Devices, Inc.. The 510(k) number is K151069.

When did SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle receive FDA 510(k) clearance?

SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle received FDA 510(k) clearance on 2016-02-05, under 510(k) number K151069.

Who is the listed applicant for SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle?

The FDA 510(k) record lists Spectra Medical Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle?

The FDA product code for SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle is BSP.

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SPECTRA 일회용 단루멘 에코성 주사 마취 전도針

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: BSP)

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