Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K191420
Device Classification Name
Oximeter
More FDA Info for this Device
510(K) Number
K191420
Device Name
Oximeter
Applicant
Shenzhen Changke Connect Electronics Co., Ltd.
A2-4th floor of Xiang dali Technology Park
No.87 of HengPing Road, Henggang, Longgang District
Shenzhen CN
Other 510(k) Applications for this Company
Contact
Yahui Zhou
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
05/28/2019
Decision Date
10/11/2019
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact