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FDA 510(k)

SmartGuard Anti-Snoring Device

K-Number: K200657 · 2021-08-23

ApplicantSmartguard Rx, Inc.
Decision Date2021-08-23
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Devices (Code: LRK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261912SnØreNegatØrDnB Innovations, LLCK261366VirtusSomnomed, Inc.K261251Snorbliss® Anti-Snoring DeviceEndeavor Commerce, LLCK261134Dormiva Anti-Snoring Mouth GuardKoncept Innovators, Inc.K252942ShaeferHShaeferh, LLCK253845Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)Ram.Shaw Pte. , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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