FDA 510(k)

하이퍼비트 비트렉토미 프로브, 23 GA, 하이퍼비트 비트렉토미 프로브, 25+, 하이퍼비트 비트렉토미 프로브, 27+

K-번호: K170520 · 2017-03-22

결정일2017-03-22

제품 코드MLZ

자문 위원회의료장비 규제 텍스트 번역 OP

결정대체적으로 동일

기기 요약

HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+ is the device name listed in this FDA 510(k) record. The listed applicant is Alcon Research, Ltd.. It received FDA 510(k) clearance on 2017-03-22 under 510(k) number K170520. The device is classified under product code MLZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+?

HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+ is a medical device that received FDA 510(k) clearance on 2017-03-22. The listed applicant is Alcon Research, Ltd.. The 510(k) number is K170520.

When did HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+ receive FDA 510(k) clearance?

HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+ received FDA 510(k) clearance on 2017-03-22, under 510(k) number K170520.

Who is the listed applicant for HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+?

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

What is the FDA product code for HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+?

The FDA product code for HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+ is MLZ.

Alcon Research, Ltd.를 신청인으로 등재한 기타 기록

K161794센트루리온 비전 시스템 (アク티브 센티리TM)

공식 출처

FDA 데이터베이스에서 보기 →

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