Peak Flow Meter

Meter, Peak Flow, Spirometry

Shanghai Sonmol Medical Equipment Co., Ltd.

The following data is part of a premarket notification filed by Shanghai Sonmol Medical Equipment Co., Ltd. with the FDA for Peak Flow Meter.

Pre-market Notification Details

Device IDK203196
510k NumberK203196
Device Name:Peak Flow Meter
ClassificationMeter, Peak Flow, Spirometry
Applicant Shanghai Sonmol Medical Equipment Co., Ltd. Room 116-118, Building 21,No.500 Jiajian Road, Jiading District Shanghai,  CN
ContactLi Yong Xu
CorrespondentRaymond Luo
Shanghai Sungo Management Consulting Company Limited 14th F, 1500# Century Avenue Shanghai,  CN 200122
Product CodeBZH  
CFR Regulation Number868.1860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-10-28
Decision Date2021-05-26

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