FDA 510(k)

The Panthera Anti-Snoring X3 Device

K-번호: K171576 · 2018-02-22

결정일2018-02-22

제품 코드LRK

자문 위원회의료 장비 규제 텍스트 번역 DE [회사명]의 [제품명]은 미국 식품의약국(FDA)에 등록된 의료 장비로, 510(k) 신청을 통해 승인을 받았습니다. 이 제품은 PMA(Premarket Approval)를 받지 않았으며, NCT(National Clinical Trial) 등록 번호는 [NCT 번호]입니다. PMID(Publication Medical Identifier)은 [PMID 번호]입니다. 더 자세한 정보는 다음 URL을 참조하세요: [URL]

결정Substantially Equivalent

기기 요약

The Panthera Anti-Snoring X3 Device is the device name listed in this FDA 510(k) record. The listed applicant is Panthera Dental, Inc.. It received FDA 510(k) clearance on 2018-02-22 under 510(k) number K171576. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the The Panthera Anti-Snoring X3 Device?

The Panthera Anti-Snoring X3 Device is a medical device that received FDA 510(k) clearance on 2018-02-22. The listed applicant is Panthera Dental, Inc.. The 510(k) number is K171576.

When did The Panthera Anti-Snoring X3 Device receive FDA 510(k) clearance?

The Panthera Anti-Snoring X3 Device received FDA 510(k) clearance on 2018-02-22, under 510(k) number K171576.

Who is the listed applicant for The Panthera Anti-Snoring X3 Device?

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

What is the FDA product code for The Panthera Anti-Snoring X3 Device?

The FDA product code for The Panthera Anti-Snoring X3 Device is LRK.

Panthera Dental, Inc.를 신청인으로 등재한 기타 기록

K203596Panthera Occlusal Appliance K192108Panthera Dental Milled Bars K183580Panthera Dental Milled Bars K173466Panthera Dental Milled Bars

공식 출처

FDA 데이터베이스에서 보기 →

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