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FDA 510(k) Application Details - K172616
Device Classification Name
Oximeter
More FDA Info for this Device
510(K) Number
K172616
Device Name
Oximeter
Applicant
Beijing Safe Heart Technology Ltd.
Room 101, Unit 6, Building NO.6
No.88 Kechuang 6th Street
Beijing Economic-Technological Developme 101111 CN
Other 510(k) Applications for this Company
Contact
Xiaoming Yang
Other 510(k) Applications for this Contact
Regulation Number
870.2700
More FDA Info for this Regulation Number
Classification Product Code
DQA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/31/2017
Decision Date
07/27/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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