FDA 510(k)

소닉 블록 투히, 소닉 블록 퀸케, 소닉 블록 치바, 소닉 블록 크로우드

K-번호: K163292 · 2017-09-08

결정일2017-09-08

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

Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford is the device name listed in this FDA 510(k) record. The listed applicant is Spectra Medical Devices. It received FDA 510(k) clearance on 2017-09-08 under 510(k) number K163292. 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 Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford?

Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford is a medical device that received FDA 510(k) clearance on 2017-09-08. The listed applicant is Spectra Medical Devices. The 510(k) number is K163292.

When did Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford receive FDA 510(k) clearance?

Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford received FDA 510(k) clearance on 2017-09-08, under 510(k) number K163292.

Who is the listed applicant for Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford?

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

What is the FDA product code for Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford?

The FDA product code for Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford is BSP.

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소닉 블록 투히, 소닉 블록 퀸케, 소닉 블록 치바, 소닉 블록 크로우드

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: BSP)

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