FDA PMA

지속적인 혈당 모니터, 임플란트형, 보조 사용

PMA 번호: P160048 · 2026-03-19

결정일2026-03-19

PMA 번호P160048

제품 코드QCD

의료기기 등급등급 3

의학적 전문분야U

자문 위원회CH [기업명]의 [제품명]은 미국 식품의약국(FDA)에서 510(k) 등록을 완료한 의료기기입니다. 이 제품은 [PMA] 및 [NCT] 등록을 완료하였으며, [PMID]로 확인할 수 있습니다. 더 자세한 정보는 다음 URL을 참조하세요: [URL].

기기 요약

Continuous glucose monitor, implanted, adjunctive use is the device name listed in this FDA 510(k) record. The listed applicant is Senseonics, Incorporated. It received FDA 510(k) clearance on 2026-03-19. The device is classified under product code QCD. It was reviewed by the CH advisory panel.

자주 묻는 질문

What is the Continuous glucose monitor, implanted, adjunctive use?

Continuous glucose monitor, implanted, adjunctive use is a medical device that received FDA 510(k) clearance on 2026-03-19. The listed applicant is Senseonics, Incorporated.

When did Continuous glucose monitor, implanted, adjunctive use receive FDA 510(k) clearance?

The clearance date for Continuous glucose monitor, implanted, adjunctive use can be found in the official FDA records.

Who is the listed applicant for Continuous glucose monitor, implanted, adjunctive use?

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

What is the FDA product code for Continuous glucose monitor, implanted, adjunctive use?

The FDA product code for Continuous glucose monitor, implanted, adjunctive use is QCD.

공식 출처

FDA 데이터베이스에서 보기 →

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

기기 요약

자주 묻는 질문

관련 임상시험

공식 출처