TRYLY AUTOMATIC WRIST BLOOD PRESSURE MONITOR

System, Measurement, Blood-pressure, Non-invasive

TRULY INSTRUMENT CO., LTD.

The following data is part of a premarket notification filed by Truly Instrument Co., Ltd. with the FDA for Tryly Automatic Wrist Blood Pressure Monitor.

Pre-market Notification Details

Device IDK113085
510k NumberK113085
Device Name:TRYLY AUTOMATIC WRIST BLOOD PRESSURE MONITOR
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant TRULY INSTRUMENT CO., LTD. 2620 CONCORD AVENUE SUITE 106 Alhambra,  CA  91803
ContactMax Wong
CorrespondentMax Wong
TRULY INSTRUMENT CO., LTD. 2620 CONCORD AVENUE SUITE 106 Alhambra,  CA  91803
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-10-18
Decision Date2012-01-12
Summary:summary

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