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FDA 510(k) Application Details - K173368
Device Classification Name
Oximeter
More FDA Info for this Device
510(K) Number
K173368
Device Name
Oximeter
Applicant
Shenzhen Coreray Technology, Ltd.
ChuangYe Technology Park
1th Dong Huan Road, Longhua New District
Shenzhen 518109 CN
Other 510(k) Applications for this Company
Contact
Simon Fan
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
10/26/2017
Decision Date
08/31/2018
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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