FDA 510(k)

도즈이 VS

K-번호: K221555 · 2022-12-15

신청자Turtle Shell Technologies Private Limited

결정일2022-12-15

제품 코드BZQ

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

Dozee VS is the device name listed in this FDA 510(k) record. The listed applicant is Turtle Shell Technologies Private Limited. It received FDA 510(k) clearance on 2022-12-15 under 510(k) number K221555. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Dozee VS?

Dozee VS is a medical device that received FDA 510(k) clearance on 2022-12-15. The listed applicant is Turtle Shell Technologies Private Limited. The 510(k) number is K221555.

When did Dozee VS receive FDA 510(k) clearance?

Dozee VS received FDA 510(k) clearance on 2022-12-15, under 510(k) number K221555.

Who is the listed applicant for Dozee VS?

The FDA 510(k) record lists Turtle Shell Technologies Private Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dozee VS?

The FDA product code for Dozee VS is BZQ.

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도즈이 VS

기기 요약

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관련 임상시험

관련 기기 (코드: BZQ)

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