FDA.report

510(k) K231276

Device
SmartCardia 7L Platform
Applicant
Smartcardia SA
510(k) number
K231276
Product code
DSI
Decision
Substantially Equivalent (SESE)
Decision date
2023-08-30
Date received
2023-05-02
Regulation
870.1025
Classification name
Detector And Alarm, Arrhythmia
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Srinivasan Murali
Address
Epfl Innovation Park Bldg. C Lausanne CH 1015 1015

FDA Registration Numbers

Source Documents

510(k) summary PDF

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