Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K201294
Device Classification Name
Oximeter
More FDA Info for this Device
510(K) Number
K201294
Device Name
Oximeter
Applicant
Guangdong Long Yao Electronic Technology Co., Ltd.
Unit A03, 2nd Floor, No. 19, Huali Road, Tianhe District
Guangzhou 510000 CN
Other 510(k) Applications for this Company
Contact
Lei Wang
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
05/14/2020
Decision Date
11/27/2020
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