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FDA 510(k)

Kangbeier Child Surgical Mask

K-Number: K221753 · 2023-12-21

ApplicantXinxiang Kangbeier Medical Technology Co., Ltd.
Decision Date2023-12-21
Product CodeOXZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Kangbeier Child Surgical Mask is a medical device manufactured by Xinxiang Kangbeier Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-12-21 under approval number K221753. The device is classified under product code OXZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Kangbeier Child Surgical Mask?

Kangbeier Child Surgical Mask is a medical device that received FDA 510(k) clearance on 2023-12-21. It is manufactured by Xinxiang Kangbeier Medical Technology Co., Ltd.. The 510(k) number is K221753.

When was Kangbeier Child Surgical Mask approved by the FDA?

Kangbeier Child Surgical Mask received FDA 510(k) clearance on 2023-12-21, under approval number K221753.

What company makes Kangbeier Child Surgical Mask?

Kangbeier Child Surgical Mask is manufactured by Xinxiang Kangbeier Medical Technology Co., Ltd..

What is the FDA product code for Kangbeier Child Surgical Mask?

The FDA product code for Kangbeier Child Surgical Mask is OXZ.

Related Clinical Trials

NCT07522281 Evaluation of an Undisturbed Embryo Culture System for Embryo Development in IVF/ICSI Cycles NOT_YET_RECRUITING NCT07515937 Occlusal Assessment of Pediatric Mandibular Fractures Managed by 3D-Printed Acrylic Occlusal Cap Splint: A Case Series RECRUITING

Other Devices by Xinxiang Kangbeier Medical Technology Co., Ltd.

K213920Kangbeier Surgical Mask (Model: KBR-1001)

Related Devices (Code: OXZ)

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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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