The iMask Child's Face Mask
K-Number: K202831 · 2021-08-26
ApplicantPac-Dent, Inc.
Decision Date2021-08-26
Product CodeOXZ
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
The iMask Child's Face Mask is a medical device manufactured by Pac-Dent, Inc.. It received FDA 510(k) clearance on 2021-08-26 under approval number K202831. 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 The iMask Child's Face Mask?
The iMask Child's Face Mask is a medical device that received FDA 510(k) clearance on 2021-08-26. It is manufactured by Pac-Dent, Inc.. The 510(k) number is K202831.
When was The iMask Child's Face Mask approved by the FDA?
The iMask Child's Face Mask received FDA 510(k) clearance on 2021-08-26, under approval number K202831.
What company makes The iMask Child's Face Mask?
The iMask Child's Face Mask is manufactured by Pac-Dent, Inc..
What is the FDA product code for The iMask Child's Face Mask?
The FDA product code for The iMask Child's Face Mask is OXZ.
Other Devices by Pac-Dent, Inc.
Related Devices (Code: OXZ)
K160100Prestige Ameritech Pediatric/Childs Face maskPrestige Ameritech
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.
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.