CER-S

Electrocardiograph, Ambulatory, With Analysis Algorithm

CardioCalm

The following data is part of a premarket notification filed by Cardiocalm with the FDA for Cer-s.

Pre-market Notification Details

Device IDK193177
510k NumberK193177
Device Name:CER-S
ClassificationElectrocardiograph, Ambulatory, With Analysis Algorithm
Applicant CardioCalm Corso Martiri Della Liberta, Nr. 40 Montichiari,  IT 25018
ContactFabio Badilini
CorrespondentFabio Badilini
CardioCalm Corso Martiri Della Liberta, Nr. 40 Montichiari,  IT 25018
Product CodeMLO  
CFR Regulation Number870.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-18
Decision Date2020-08-26

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.