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 a medical device manufactured by Smartguard Rx, Inc.. It received FDA 510(k) clearance on 2021-08-23 under approval 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. It is manufactured by Smartguard Rx, Inc.. The 510(k) number is K200657.
When was SmartGuard Anti-Snoring Device approved by the FDA?
SmartGuard Anti-Snoring Device received FDA 510(k) clearance on 2021-08-23, under approval number K200657.
What company makes SmartGuard Anti-Snoring Device?
SmartGuard Anti-Snoring Device is manufactured by Smartguard Rx, Inc..
What is the FDA product code for SmartGuard Anti-Snoring Device?
The FDA product code for SmartGuard Anti-Snoring Device is LRK.
Related Clinical Trials
Related Devices (Code: LRK)
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.