FDA 510(k)

Prosomnus [CA] Устройство для сна и храпа и Prosomnus [CA] Устройство для сна и храпа с микро-рекордером

Номер K: K172859 · 2017-11-22

Дата решения2017-11-22

Код продуктаPLC

Консультативный комитетDE

РешениеSubstantially Equivalent

Описание устройства

Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder is the device name listed in this FDA 510(k) record. The listed applicant is Prosomnous Sleep Technologies. It received FDA 510(k) clearance on 2017-11-22 under 510(k) number K172859. The device is classified under product code PLC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder?

Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder is a medical device that received FDA 510(k) clearance on 2017-11-22. The listed applicant is Prosomnous Sleep Technologies. The 510(k) number is K172859.

When did Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder receive FDA 510(k) clearance?

Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder received FDA 510(k) clearance on 2017-11-22, under 510(k) number K172859.

Who is the listed applicant for Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder?

The FDA 510(k) record lists Prosomnous Sleep Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder?

The FDA product code for Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder is PLC.

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: PLC)

K254304iNOS intraoral biosensorAchaemenid, LLC K252765ProSomnus RPMO2 OSA Device (RPMO2 OSA)Prosomnus Sleep Technologies K233497Rest Assure SystemSomnomed, Inc.K190353Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTracResidential Home Sleep Services K181571OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient MonitorMark Abramson, D.D.S., Inc.K170606Акриловый Herbst Аппарат с Микро-РекордеромGergen'S Orthodontic Lab

Официальный источник

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