Pulmogine Vibrating Mesh Nebulizer

Nebulizer (direct Patient Interface)

HCMed Innovations Co., Ltd.

The following data is part of a premarket notification filed by Hcmed Innovations Co., Ltd. with the FDA for Pulmogine Vibrating Mesh Nebulizer.

Pre-market Notification Details

Device IDK202171
510k NumberK202171
Device Name:Pulmogine Vibrating Mesh Nebulizer
ClassificationNebulizer (direct Patient Interface)
Applicant HCMed Innovations Co., Ltd. Rm.B, 10F, No.319, Sec.2, Dunhua S. Rd., Da-an District, Taipei City,  TW 10669
ContactYiling Lee
CorrespondentYiling Lee
HCMed Innovations Co., Ltd. Rm.B, 10F, No.319, Sec.2, Dunhua S. Rd., Da-an District, Taipei City,  TW 10669
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-03
Decision Date2021-07-01

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