FDA 510(k)

Strome-Blitzer Cytology Balloon

Номер K: K182159 · 2019-06-13

Дата решения2019-06-13

Код продуктаEOX

Консультативный комитетEN

РешениеSubstantially Equivalent

Описание устройства

Strome-Blitzer Cytology Balloon is the device name listed in this FDA 510(k) record. The listed applicant is Adn International, LLC. It received FDA 510(k) clearance on 2019-06-13 under 510(k) number K182159. The device is classified under product code EOX. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Strome-Blitzer Cytology Balloon?

Strome-Blitzer Cytology Balloon is a medical device that received FDA 510(k) clearance on 2019-06-13. The listed applicant is Adn International, LLC. The 510(k) number is K182159.

When did Strome-Blitzer Cytology Balloon receive FDA 510(k) clearance?

Strome-Blitzer Cytology Balloon received FDA 510(k) clearance on 2019-06-13, under 510(k) number K182159.

Who is the listed applicant for Strome-Blitzer Cytology Balloon?

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

What is the FDA product code for Strome-Blitzer Cytology Balloon?

The FDA product code for Strome-Blitzer Cytology Balloon is EOX.

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.

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Связанные устройства (Код: EOX)

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Официальный источник

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