PC ECG

Electrocardiograph

EDAN INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Pc Ecg.

Pre-market Notification Details

Device IDK161302
510k NumberK161302
Device Name:PC ECG
ClassificationElectrocardiograph
Applicant EDAN INSTRUMENTS, INC. 3/F - B, NANSHAN MEDICAL EQUIPMENTS PARK, NANHAI RD 1019# Shenzhen,  CN 518067
ContactErico Li
CorrespondentDoug Worth
EDAN MEDICAL 1200 CROSSMAN AVE. SUITE 200 Sunnyvale,  CA  94089
Product CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-05-09
Decision Date2016-07-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06944413802759 K161302 000

Trademark Results [PC ECG]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PC ECG
PC ECG
78322450 not registered Dead/Abandoned
BTS Holdings
2003-11-03

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