Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)
K-Number: K253845 · 2026-03-03
ApplicantRam.Shaw Pte. , Ltd.
Decision Date2026-03-03
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB) is a medical device manufactured by Ram.Shaw Pte. , Ltd.. It received FDA 510(k) clearance on 2026-03-03 under approval number K253845. 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 Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)?
Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB) is a medical device that received FDA 510(k) clearance on 2026-03-03. It is manufactured by Ram.Shaw Pte. , Ltd.. The 510(k) number is K253845.
When was Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB) approved by the FDA?
Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB) received FDA 510(k) clearance on 2026-03-03, under approval number K253845.
What company makes Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)?
Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB) is manufactured by Ram.Shaw Pte. , Ltd..
What is the FDA product code for Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)?
The FDA product code for Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB) is LRK.
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.