Vital Signs Monitor

Oximeter

Edan Instruments, Inc.

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

Pre-market Notification Details

Device IDK180380
510k NumberK180380
Device Name:Vital Signs Monitor
ClassificationOximeter
Applicant Edan Instruments, Inc. #15 Jinhui Road,Jinsha Community Kengzi Sub-District Pingshan District Shenzhen,  CN 518122
ContactAlice Yang
CorrespondentDoug Worth
Edan Medical 1200 Crossman Ave. Suite 200 Sunnyvale,  CA  94089
Product CodeDQA  
Subsequent Product CodeDXN
Subsequent Product CodeFLL
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-02-12
Decision Date2018-12-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06944413808812 K180380 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.