FDA 510(k)

Dukal Corporation Level 1 Pediatric Face Mask

Número K: K210321 · 2022-03-29

Data da decisão2022-03-29

Código do produtoOXZ

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Dukal Corporation Level 1 Pediatric Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Dukal Corporation. It received FDA 510(k) clearance on 2022-03-29 under 510(k) number K210321. The device is classified under product code OXZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Dukal Corporation Level 1 Pediatric Face Mask?

Dukal Corporation Level 1 Pediatric Face Mask is a medical device that received FDA 510(k) clearance on 2022-03-29. The listed applicant is Dukal Corporation. The 510(k) number is K210321.

When did Dukal Corporation Level 1 Pediatric Face Mask receive FDA 510(k) clearance?

Dukal Corporation Level 1 Pediatric Face Mask received FDA 510(k) clearance on 2022-03-29, under 510(k) number K210321.

Who is the listed applicant for Dukal Corporation Level 1 Pediatric Face Mask?

The FDA 510(k) record lists Dukal Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dukal Corporation Level 1 Pediatric Face Mask?

The FDA product code for Dukal Corporation Level 1 Pediatric Face Mask is OXZ.

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Outros registros que listam Dukal Corporation como candidato(a)

K212464Dukal Corporation AAMI Level 4 Open-Back Protective Gown K203237Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown K201732Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On K201421Dukal Corporation Level 2 Surgical Mask with Ear Loops; Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield; Dukal Corporation Level 2 Surgical Mask with Adjustable Tie Ons

Dispositivos Relacionados (Código: OXZ)

K221753Kangbeier Child Surgical MaskXinxiang Kangbeier Medical Technology Co., Ltd.K213427PRIMED Pediatric FacemaskPrimed Medical Products, Inc.K201514Child 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

Fonte oficial

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