FDA 510(k)

防打鼾口腔器（L08-BP，L08-PT，L08-BT，L08-TP，L08-TB，L08-PB）

K号: K253845 · 2026-03-03

决定日期2026-03-03

产品代码LRK

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决定实质等同

器械摘要

Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB) is the device name listed in this FDA 510(k) record. The listed applicant is Ram.Shaw Pte. , Ltd.. It received FDA 510(k) clearance on 2026-03-03 under 510(k) number K253845. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

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. The listed applicant is Ram.Shaw Pte. , Ltd.. The 510(k) number is K253845.

When did Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB) receive FDA 510(k) clearance?

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 510(k) number K253845.

Who is the listed applicant for Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)?

The FDA 510(k) record lists Ram.Shaw Pte. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

列明Ram.Shaw Pte. , Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K262104防打鼾口腔器（L09-BB，L09-PP，L09-TB，L09-BT，L09-TP，L09-PT，L09-TT）

官方来源

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