IHEALTH FINGERTIP PULSE OXIMETER

Oximeter

ANDON HEALTH CO.,LTD

The following data is part of a premarket notification filed by Andon Health Co.,ltd with the FDA for Ihealth Fingertip Pulse Oximeter.

Pre-market Notification Details

Device IDK131111
510k NumberK131111
Device Name:IHEALTH FINGERTIP PULSE OXIMETER
ClassificationOximeter
Applicant ANDON HEALTH CO.,LTD #3, JIN PING STREET YA AN RD NANKAI DISTRICT Tianjin,  CN 300190
ContactLiu Yi
CorrespondentLiu Yi
ANDON HEALTH CO.,LTD #3, JIN PING STREET YA AN RD NANKAI DISTRICT Tianjin,  CN 300190
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-04-19
Decision Date2013-09-11
Summary:summary

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