BESTNEB PORTABLE AEROSOL THERAPY UNIT, AP-100100

Nebulizer (direct Patient Interface)

APEX MEDICAL CORP.

The following data is part of a premarket notification filed by Apex Medical Corp. with the FDA for Bestneb Portable Aerosol Therapy Unit, Ap-100100.

Pre-market Notification Details

Device IDK990435
510k NumberK990435
Device Name:BESTNEB PORTABLE AEROSOL THERAPY UNIT, AP-100100
ClassificationNebulizer (direct Patient Interface)
Applicant APEX MEDICAL CORP. 10TH FLOOR, NO.31, LANE 169 KANG NING STREET Hsi-chih City, Taipei Hsien,  TW
ContactDaniel Lee
CorrespondentDaniel Lee
APEX MEDICAL CORP. 10TH FLOOR, NO.31, LANE 169 KANG NING STREET Hsi-chih City, Taipei Hsien,  TW
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-02-11
Decision Date2000-06-05

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