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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 the device name listed in this FDA 510(k) record. The listed applicant is Xinxiang Kangbeier Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-12-21 under 510(k) 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. The listed applicant is Xinxiang Kangbeier Medical Technology Co., Ltd.. The 510(k) number is K221753.

When did Kangbeier Child Surgical Mask receive FDA 510(k) clearance?

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

Who is the listed applicant for Kangbeier Child Surgical Mask?

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

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

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

Other records listing Xinxiang Kangbeier Medical Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K213920Kangbeier Surgical Mask (Model: KBR-1001)

Related Devices (Code: OXZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K213427PRIMED Pediatric FacemaskPrimed Medical Products, Inc.K210321Dukal Corporation Level 1 Pediatric Face MaskDukal CorporationK201514Child Face MaskShandong Shengquan New Material Co., Ltd.K202831The iMask Child's Face MaskPac-Dent, Inc.K190308Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks, Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1)Amd Medicom, Inc.K160100Prestige Ameritech Pediatric/Child’s Face maskPrestige Ameritech

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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