FDA 510(k)

OtoSet- Ear Cleaning System

Номер K: K201877 · 2020-11-05

ЗаявительSafkan, Inc.

Дата решения2020-11-05

Код продуктаKYZ

Консультативный комитетHO

РешениеSubstantially Equivalent

Описание устройства

OtoSet- Ear Cleaning System is the device name listed in this FDA 510(k) record. The listed applicant is Safkan, Inc.. It received FDA 510(k) clearance on 2020-11-05 under 510(k) number K201877. The device is classified under product code KYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the OtoSet- Ear Cleaning System?

OtoSet- Ear Cleaning System is a medical device that received FDA 510(k) clearance on 2020-11-05. The listed applicant is Safkan, Inc.. The 510(k) number is K201877.

When did OtoSet- Ear Cleaning System receive FDA 510(k) clearance?

OtoSet- Ear Cleaning System received FDA 510(k) clearance on 2020-11-05, under 510(k) number K201877.

Who is the listed applicant for OtoSet- Ear Cleaning System?

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

What is the FDA product code for OtoSet- Ear Cleaning System?

The FDA product code for OtoSet- Ear Cleaning System is KYZ.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Официальный источник

Посмотреть в базе данных FDA →

Данные получены из открытого API FDA. Для получения наиболее актуальной и авторитетной информации всегда обращайтесь к официальным записям.