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FDA 510(k) Application Details - K203196
Device Classification Name
Meter, Peak Flow, Spirometry
More FDA Info for this Device
510(K) Number
K203196
Device Name
Meter, Peak Flow, Spirometry
Applicant
Shanghai Sonmol Medical Equipment Co., Ltd.
Room 116-118, Building 21,No.500 Jiajian Road,
Jiading District
Shanghai CN
Other 510(k) Applications for this Company
Contact
Li Yong Xu
Other 510(k) Applications for this Contact
Regulation Number
868.1860
More FDA Info for this Regulation Number
Classification Product Code
BZH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/28/2020
Decision Date
05/26/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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