H100B PULSE OXIMETER

Oximeter

EDAN INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for H100b Pulse Oximeter.

Pre-market Notification Details

Device IDK092727
510k NumberK092727
Device Name:H100B PULSE OXIMETER
ClassificationOximeter
Applicant EDAN INSTRUMENTS, INC. SUITE 8D, NO.19, LANE 999 ZHONGSHAN ROAD (S-2) Shanghai,  CN 200030
ContactLi Fu
CorrespondentLi Fu
EDAN INSTRUMENTS, INC. SUITE 8D, NO.19, LANE 999 ZHONGSHAN ROAD (S-2) Shanghai,  CN 200030
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-09-04
Decision Date2009-12-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00815871021074 K092727 000
00815871021067 K092727 000

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