RTT DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL RTW-8010A

System, Measurement, Blood-pressure, Non-invasive

REAL TONE TECHNOLOGY CORP.

The following data is part of a premarket notification filed by Real Tone Technology Corp. with the FDA for Rtt Digital Wrist Blood Pressure Monitor, Model Rtw-8010a.

Pre-market Notification Details

Device IDK060077
510k NumberK060077
Device Name:RTT DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL RTW-8010A
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant REAL TONE TECHNOLOGY CORP. XI HUANG ROAD; XINZHUANG TOWN Shanghai,  CN 201110
ContactTom Wang
CorrespondentTom Wang
REAL TONE TECHNOLOGY CORP. XI HUANG ROAD; XINZHUANG TOWN Shanghai,  CN 201110
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-01-10
Decision Date2006-03-08

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