FDA 510(k)

포터블 메시 뿌리기기 (JM821)

K-번호: K244035 · 2025-09-19

신청자Shenzhen Jermei Medical Device Technology Co., Ltd.

결정일2025-09-19

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

결정대체적으로 동일

기기 요약

Portable mesh nebulizer (JM821) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Jermei Medical Device Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-09-19 under 510(k) number K244035. 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 mesh nebulizer (JM821)?

Portable mesh nebulizer (JM821) is a medical device that received FDA 510(k) clearance on 2025-09-19. The listed applicant is Shenzhen Jermei Medical Device Technology Co., Ltd.. The 510(k) number is K244035.

When did Portable mesh nebulizer (JM821) receive FDA 510(k) clearance?

Portable mesh nebulizer (JM821) received FDA 510(k) clearance on 2025-09-19, under 510(k) number K244035.

Who is the listed applicant for Portable mesh nebulizer (JM821)?

The FDA 510(k) record lists Shenzhen Jermei Medical Device Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Portable mesh nebulizer (JM821)?

The FDA product code for Portable mesh nebulizer (JM821) is CAF.

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FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.

포터블 메시 뿌리기기 (JM821)

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: CAF)

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