FDA 510(k)

SmartGuard Anti-Snoring Device

Número K: K200657 · 2021-08-23

Data da decisão2021-08-23

Código do produtoLRK

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

SmartGuard Anti-Snoring Device is the device name listed in this FDA 510(k) record. The listed applicant is Smartguard Rx, Inc.. It received FDA 510(k) clearance on 2021-08-23 under 510(k) number K200657. 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 SmartGuard Anti-Snoring Device?

SmartGuard Anti-Snoring Device is a medical device that received FDA 510(k) clearance on 2021-08-23. The listed applicant is Smartguard Rx, Inc.. The 510(k) number is K200657.

When did SmartGuard Anti-Snoring Device receive FDA 510(k) clearance?

SmartGuard Anti-Snoring Device received FDA 510(k) clearance on 2021-08-23, under 510(k) number K200657.

Who is the listed applicant for SmartGuard Anti-Snoring Device?

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

What is the FDA product code for SmartGuard Anti-Snoring Device?

The FDA product code for SmartGuard Anti-Snoring Device is LRK.

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