FDA 510(k)

VPAP Pediatric Face Mask

Número K: K251888 · 2026-03-12

Data da decisão2026-03-12

Código do produtoCBK

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

VPAP Pediatric Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Hsiner Co., Ltd.. It received FDA 510(k) clearance on 2026-03-12 under 510(k) number K251888. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the VPAP Pediatric Face Mask?

VPAP Pediatric Face Mask is a medical device that received FDA 510(k) clearance on 2026-03-12. The listed applicant is Hsiner Co., Ltd.. The 510(k) number is K251888.

When did VPAP Pediatric Face Mask receive FDA 510(k) clearance?

VPAP Pediatric Face Mask received FDA 510(k) clearance on 2026-03-12, under 510(k) number K251888.

Who is the listed applicant for VPAP Pediatric Face Mask?

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

What is the FDA product code for VPAP Pediatric Face Mask?

The FDA product code for VPAP Pediatric Face Mask is CBK.

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