Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K212385
Device Classification Name
Oximeter
More FDA Info for this Device
510(K) Number
K212385
Device Name
Oximeter
Applicant
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
Yunyang Industrial Park
Danyang 212300 CN
Other 510(k) Applications for this Company
Contact
Yuzhuo 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
08/02/2021
Decision Date
08/16/2022
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