DISPOSABLE NEBULIZER SET

Nebulizer (direct Patient Interface)

SUZHOU WEIKANG MEDICAL APPARATUS CO., LTD

The following data is part of a premarket notification filed by Suzhou Weikang Medical Apparatus Co., Ltd with the FDA for Disposable Nebulizer Set.

Pre-market Notification Details

Device IDK140237
510k NumberK140237
Device Name:DISPOSABLE NEBULIZER SET
ClassificationNebulizer (direct Patient Interface)
Applicant SUZHOU WEIKANG MEDICAL APPARATUS CO., LTD 7TH FL. JINGUI BUSINESS BUIDLING NO. 982 CONGYUN RD, BAIYUN DISTRICT Guangzhou, Guangdong,  CN 510420
ContactMike Gu
CorrespondentMike Gu
SUZHOU WEIKANG MEDICAL APPARATUS CO., LTD 7TH FL. JINGUI BUSINESS BUIDLING NO. 982 CONGYUN RD, BAIYUN DISTRICT Guangzhou, Guangdong,  CN 510420
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-01-30
Decision Date2015-01-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
40612479231670 K140237 000
00616784560731 K140237 000
00616784561738 K140237 000
10850005165108 K140237 000
10850005165092 K140237 000
10850005165085 K140237 000
10850005165078 K140237 000

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