Current Health Monitoring System Gen 2 (G2)

System, Network And Communication, Physiological Monitors

Current Health

The following data is part of a premarket notification filed by Current Health with the FDA for Current Health Monitoring System Gen 2 (g2).

Pre-market Notification Details

Device IDK210133
510k NumberK210133
Device Name:Current Health Monitoring System Gen 2 (G2)
ClassificationSystem, Network And Communication, Physiological Monitors
Applicant Current Health Playfair House, 6 Broughton Street Lane Edinburgh,  GB Eh 1 3ly
ContactPhil Bromley
CorrespondentPhil Bromley
Current Health Playfair House, 6 Broughton Street Lane Edinburgh,  GB Eh 1 3ly
Product CodeMSX  
Subsequent Product CodeBZG
Subsequent Product CodeDQA
Subsequent Product CodeDRG
Subsequent Product CodeFLL
Subsequent Product CodeGZQ
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-19
Decision Date2021-09-03

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