READMYHEART, MODEL RMH2.0

Electrocardiograph

DAILYCARE BIOMEDICAL INC

The following data is part of a premarket notification filed by Dailycare Biomedical Inc with the FDA for Readmyheart, Model Rmh2.0.

Pre-market Notification Details

Device IDK052303
510k NumberK052303
Device Name:READMYHEART, MODEL RMH2.0
ClassificationElectrocardiograph
Applicant DAILYCARE BIOMEDICAL INC 8F, 25-3 JI-LIN ROAD Chungli,  TW 320
ContactDaniel J. H. Chang
CorrespondentDaniel J. H. Chang
DAILYCARE BIOMEDICAL INC 8F, 25-3 JI-LIN ROAD Chungli,  TW 320
Product CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-08-24
Decision Date2005-12-16
Summary:summary

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