FDA 510(k)

CEFALY 연결 - OTC, CEFALY 연결 - RX

K-번호: K234029 · 2024-07-18

결정일2024-07-18

제품 코드PCC

자문 위원회NE (이 문서는 원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.)

결정대체적으로 동일

기기 요약

CEFALY Connected - OTC, CEFALY Connected - Rx is the device name listed in this FDA 510(k) record. The listed applicant is Cefaly Technology. It received FDA 510(k) clearance on 2024-07-18 under 510(k) number K234029. The device is classified under product code PCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the CEFALY Connected - OTC, CEFALY Connected - Rx?

CEFALY Connected - OTC, CEFALY Connected - Rx is a medical device that received FDA 510(k) clearance on 2024-07-18. The listed applicant is Cefaly Technology. The 510(k) number is K234029.

When did CEFALY Connected - OTC, CEFALY Connected - Rx receive FDA 510(k) clearance?

CEFALY Connected - OTC, CEFALY Connected - Rx received FDA 510(k) clearance on 2024-07-18, under 510(k) number K234029.

Who is the listed applicant for CEFALY Connected - OTC, CEFALY Connected - Rx?

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

What is the FDA product code for CEFALY Connected - OTC, CEFALY Connected - Rx?

The FDA product code for CEFALY Connected - OTC, CEFALY Connected - Rx is PCC.

Cefaly Technology를 신청인으로 등재한 기타 기록

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