FDA 510(k)

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K-번호: K230379 · 2023-11-27

신청자Dongguan Simzo Electronic Technology Co., Ltd.

결정일2023-11-27

제품 코드CAF

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

Portable (Ultrasonic) Nebulizer is the device name listed in this FDA 510(k) record. The listed applicant is Dongguan Simzo Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-11-27 under 510(k) number K230379. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Portable (Ultrasonic) Nebulizer?

Portable (Ultrasonic) Nebulizer is a medical device that received FDA 510(k) clearance on 2023-11-27. The listed applicant is Dongguan Simzo Electronic Technology Co., Ltd.. The 510(k) number is K230379.

When did Portable (Ultrasonic) Nebulizer receive FDA 510(k) clearance?

Portable (Ultrasonic) Nebulizer received FDA 510(k) clearance on 2023-11-27, under 510(k) number K230379.

Who is the listed applicant for Portable (Ultrasonic) Nebulizer?

The FDA 510(k) record lists Dongguan Simzo Electronic Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Portable (Ultrasonic) Nebulizer?

The FDA product code for Portable (Ultrasonic) Nebulizer is CAF.

Dongguan Simzo Electronic Technology Co., Ltd.를 신청인으로 등재한 기타 기록

K211583인프라레드 체온계, 모델: HW-1 K173048비접촉 전額 체온계

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