Coala Heart Monitor

Electrocardiograph

Coala Life AB

The following data is part of a premarket notification filed by Coala Life Ab with the FDA for Coala Heart Monitor.

Pre-market Notification Details

Device IDK212163
510k NumberK212163
Device Name:Coala Heart Monitor
ClassificationElectrocardiograph
Applicant Coala Life AB Kalsangsgrand 10B Uppsala,  SE 75319
ContactDan Pitulia
CorrespondentPierre Bounaud
AcKnowledge Regulatory Strategies 2251 San Diego Ave, Suite B-257 San Diego,  CA  92110
Product CodeDPS  
Subsequent Product CodeDQC
Subsequent Product CodeDQD
Subsequent Product CodeDXH
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-12
Decision Date2022-04-14

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.