FDA.reportPublic FDA data

510(k) K222370

Device
SpO2 Extension Cable
Applicant
Beijing Rongrui-Century Science & Technology Co., Ltd.
510(k) number
K222370
Product code
DSA
Decision
Substantially Equivalent (SESE)
Decision date
2023-04-02
Date received
2022-08-05
Regulation
870.2900
Classification name
Cable, Transducer And Electrode, Patient, (Including Connector)
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Calen Chen
Address
3rd Floor, W. Zone, #1 Bldg., #7 Yard, Fengxian Middle Rd., Haidian District Beijing CN 100094 100094

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DSA#

510(k), Device, Applicant table
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