FDA 510(k)

필립스 아벤티 듀얼 전기 모유 펌프 고급 SCF394/61, 필립스 아벤티 듀얼 전기 모유 펌프 고급 SCF394/62

K-번호: K203383 · 2020-12-15

신청자Philips Consumer Lifestyle - Innovation Site Eindhoven

결정일2020-12-15

제품 코드HGX

자문 위원회의료장비 규제 텍스트 번역 [기업명]의 [제품명]은 미국 식품의약국(FDA)에 등록된 의료장비로, 510(k) 신청을 통해 승인받았습니다. PMA(Premarket Approval) 신청이 진행 중이며, 연구 등록 번호(NCT)는 [NCT 번호]입니다. 논문 등록 번호(PMID)는 [PMID 번호]입니다. 더 자세한 정보는 다음 URL을 참조하세요: [URL]

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기기 요약

Philips Avent Double electric breast pump Advanced SCF394/61, Philips Avent Double electric breast pump Advanced SCF394/62 is the device name listed in this FDA 510(k) record. The listed applicant is Philips Consumer Lifestyle - Innovation Site Eindhoven. It received FDA 510(k) clearance on 2020-12-15 under 510(k) number K203383. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Philips Avent Double electric breast pump Advanced SCF394/61, Philips Avent Double electric breast pump Advanced SCF394/62?

Philips Avent Double electric breast pump Advanced SCF394/61, Philips Avent Double electric breast pump Advanced SCF394/62 is a medical device that received FDA 510(k) clearance on 2020-12-15. The listed applicant is Philips Consumer Lifestyle - Innovation Site Eindhoven. The 510(k) number is K203383.

When did Philips Avent Double electric breast pump Advanced SCF394/61, Philips Avent Double electric breast pump Advanced SCF394/62 receive FDA 510(k) clearance?

Philips Avent Double electric breast pump Advanced SCF394/61, Philips Avent Double electric breast pump Advanced SCF394/62 received FDA 510(k) clearance on 2020-12-15, under 510(k) number K203383.

Who is the listed applicant for Philips Avent Double electric breast pump Advanced SCF394/61, Philips Avent Double electric breast pump Advanced SCF394/62?

The FDA 510(k) record lists Philips Consumer Lifestyle - Innovation Site Eindhoven as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Philips Avent Double electric breast pump Advanced SCF394/61, Philips Avent Double electric breast pump Advanced SCF394/62?

The FDA product code for Philips Avent Double electric breast pump Advanced SCF394/61, Philips Avent Double electric breast pump Advanced SCF394/62 is HGX.

Philips Consumer Lifestyle - Innovation Site Eindhoven를 신청인으로 등재한 기타 기록

K201381필립스 아벤티 싱글/둘레 전기 모유 펌프 고급 K161532필립스 애벤트 컴포트 싱글/트윈 전기 모유 펌프

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