IM60/IM70 PATIENT MONITOR

Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

EDAN INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Im60/im70 Patient Monitor.

Pre-market Notification Details

Device IDK131971
510k NumberK131971
Device Name:IM60/IM70 PATIENT MONITOR
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant EDAN INSTRUMENTS, INC. NANHAI RD 1019 NO. SHEKOU, NANSHAN Shenzhen, Guangdong,  CN 518067
ContactCherry Sun
CorrespondentCherry Sun
EDAN INSTRUMENTS, INC. NANHAI RD 1019 NO. SHEKOU, NANSHAN Shenzhen, Guangdong,  CN 518067
Product CodeMHX  
Subsequent Product CodeCBQ
Subsequent Product CodeCBR
Subsequent Product CodeCBS
Subsequent Product CodeCCK
Subsequent Product CodeCCL
Subsequent Product CodeDQA
Subsequent Product CodeDRT
Subsequent Product CodeDSA
Subsequent Product CodeDSI
Subsequent Product CodeDSK
Subsequent Product CodeDXN
Subsequent Product CodeFLL
Subsequent Product CodeMLD
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-06-28
Decision Date2014-03-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00815871021913 K131971 000
00815871021029 K131971 000
00815871021036 K131971 000
00815871021043 K131971 000
00815871021050 K131971 000
00815871021180 K131971 000
00815871021197 K131971 000
00815871021203 K131971 000
00815871021210 K131971 000
00815871021470 K131971 000
00815871021012 K131971 000

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