Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless)

Oximeter

Leadtek Research Inc.

The following data is part of a premarket notification filed by Leadtek Research Inc. with the FDA for Leadtek Fingertip Pulse Oximeter (wireless), Leadtek Fingertip Pulse Oximeter (wireless).

Pre-market Notification Details

Device IDK210032
510k NumberK210032
Device Name:Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless)
ClassificationOximeter
Applicant Leadtek Research Inc. 18F, No. 166, Jian-Yi Rd., Chung Ho Dist. New Taipei City,  TW 23511
ContactKun-shan Lu
CorrespondentSharon Peng
Leadtek Research Inc. 18F, No. 166, Jian-Yi Rd., Chung Ho Dist. New Taipei City,  TW 23511
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-05
Decision Date2021-09-01

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