Finger Type Pulse Oximeter

Oximeter

TAIDOC TECHNOLOGY CORPORATION

The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Finger Type Pulse Oximeter.

Pre-market Notification Details

Device IDK151024
510k NumberK151024
Device Name:Finger Type Pulse Oximeter
ClassificationOximeter
Applicant TAIDOC TECHNOLOGY CORPORATION 6F, NO. 127, WUGONG 2ND RD., WUGU DISTRICT New Taipei City,  TW 24888
ContactC. W. Chen
CorrespondentSharon Peng
TAIDOC TECHNOLOGY CORPORATION 6F, NO. 127, WUGONG 2ND RD WUGU DISTRICT New Taipei City,  TW 24888
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-04-16
Decision Date2016-03-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816042011764 K151024 000
00816042013553 K151024 000

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