FDA 510(k)

ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring

Número K: K221889 · 2022-10-06

Data da decisão2022-10-06

Código do produtoLRK

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring is the device name listed in this FDA 510(k) record. The listed applicant is Prosomnus Sleep Technologies. It received FDA 510(k) clearance on 2022-10-06 under 510(k) number K221889. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring?

ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring is a medical device that received FDA 510(k) clearance on 2022-10-06. The listed applicant is Prosomnus Sleep Technologies. The 510(k) number is K221889.

When did ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring receive FDA 510(k) clearance?

ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring received FDA 510(k) clearance on 2022-10-06, under 510(k) number K221889.

Who is the listed applicant for ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring?

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

What is the FDA product code for ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring?

The FDA product code for ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring is LRK.

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Outros registros que listam Prosomnus Sleep Technologies como candidato(a)

K252765ProSomnus RPMO2 OSA Device (RPMO2 OSA)

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Fonte oficial

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