FDA.report

510(k) K212300

Device
Pulse Oximeter
Applicant
Shenzhen Mericonn Technology Co., Ltd.
510(k) number
K212300
Product code
DQA  
Decision
Substantially Equivalent (SESE)
Decision date
2022-02-25
Date received
2021-07-22
Regulation
870.2700
Classification name
Oximeter
Medical specialty
Cardiovascular
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Jiang Chuanyuan
Address
Rm. 20203, Bldg. 6, Donglongxing Kejiyuan, Huaning Rd. Xinshishequ, Dalang St. Shenzhen CN 518109 518109

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Legacy Summary

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases