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FDA 510(k)

VPAP Pediatric Face Mask

K-Number: K251888 · 2026-03-12

ApplicantHsiner Co., Ltd.
Decision Date2026-03-12
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Hsiner Co., Ltd.. The 510(k) number is K251888.

When was VPAP Pediatric Face Mask approved by the FDA?

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

What company makes VPAP Pediatric Face Mask?

VPAP Pediatric Face Mask is manufactured by Hsiner Co., Ltd..

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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Official Source

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

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