RA-T59 Wrist Blood Pressure Monitor

System, Measurement, Blood-pressure, Non-invasive

LotusNine Medical Limited

The following data is part of a premarket notification filed by Lotusnine Medical Limited with the FDA for Ra-t59 Wrist Blood Pressure Monitor.

Pre-market Notification Details

Device IDK212312
510k NumberK212312
Device Name:RA-T59 Wrist Blood Pressure Monitor
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant LotusNine Medical Limited No. 2, Ln. 223, Sec. 1, Taiping Rd., Tsaotun Township Nantou County,  TW 524007
ContactYating Chang
CorrespondentYuhua Chen
PuHsu Consulting Ltd. 7F., No.272, Jiankang Rd., Zhonghe Dist. New Taipei City,  TW 235042
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-23
Decision Date2022-01-27

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