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FDA 510(k)

Prestige Ameritech Pediatric/Child’s Face mask

K-Number: K160100 · 2016-10-07

ApplicantPrestige Ameritech
Decision Date2016-10-07
Product CodeOXZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Prestige Ameritech Pediatric/Child’s Face mask is a medical device manufactured by Prestige Ameritech. It received FDA 510(k) clearance on 2016-10-07 under approval number K160100. 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 Prestige Ameritech Pediatric/Child’s Face mask?

Prestige Ameritech Pediatric/Child’s Face mask is a medical device that received FDA 510(k) clearance on 2016-10-07. It is manufactured by Prestige Ameritech. The 510(k) number is K160100.

When was Prestige Ameritech Pediatric/Child’s Face mask approved by the FDA?

Prestige Ameritech Pediatric/Child’s Face mask received FDA 510(k) clearance on 2016-10-07, under approval number K160100.

What company makes Prestige Ameritech Pediatric/Child’s Face mask?

Prestige Ameritech Pediatric/Child’s Face mask is manufactured by Prestige Ameritech.

What is the FDA product code for Prestige Ameritech Pediatric/Child’s Face mask?

The FDA product code for Prestige Ameritech Pediatric/Child’s Face mask is OXZ.

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Other Devices by Prestige Ameritech

K171162Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield K231741ProGear® Surgical Mask with Oxafence®, Model AV82030

Related Devices (Code: OXZ)

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. K201514Child Face MaskShandong Shengquan New Material Co., Ltd. K202831The iMask Child's Face MaskPac-Dent, Inc. K213427PRIMED Pediatric FacemaskPrimed Medical Products, Inc. K210321Dukal Corporation Level 1 Pediatric Face MaskDukal Corporation K221753Kangbeier Child Surgical MaskXinxiang Kangbeier Medical Technology Co., Ltd.

Official Source

View on FDA Database →

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

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