FDA 510(k)

Diamond Digital Sleep Orthotic (DDSO)

Номер K: K202499 · 2020-09-03

Дата решения2020-09-03

Код продуктаLRK

Консультативный комитетDE

РешениеSubstantially Equivalent

Описание устройства

Diamond Digital Sleep Orthotic (DDSO) is the device name listed in this FDA 510(k) record. The listed applicant is Diamond Orthotic Laboratory. It received FDA 510(k) clearance on 2020-09-03 under 510(k) number K202499. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Diamond Digital Sleep Orthotic (DDSO)?

Diamond Digital Sleep Orthotic (DDSO) is a medical device that received FDA 510(k) clearance on 2020-09-03. The listed applicant is Diamond Orthotic Laboratory. The 510(k) number is K202499.

When did Diamond Digital Sleep Orthotic (DDSO) receive FDA 510(k) clearance?

Diamond Digital Sleep Orthotic (DDSO) received FDA 510(k) clearance on 2020-09-03, under 510(k) number K202499.

Who is the listed applicant for Diamond Digital Sleep Orthotic (DDSO)?

The FDA 510(k) record lists Diamond Orthotic Laboratory as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Diamond Digital Sleep Orthotic (DDSO)?

The FDA product code for Diamond Digital Sleep Orthotic (DDSO) is LRK.

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: LRK)

K262104Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)Ram.Shaw Pte., Ltd.K261912SnØreNegatØrDnB Innovations, LLC K261366VirtusSomnomed, Inc.K261251Snorbliss® Anti-Snoring DeviceEndeavor Commerce, LLC K261134Dormiva Anti-Snoring Mouth GuardKoncept Innovators, Inc.K252942ShaeferHShaeferh, LLC

Официальный источник

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