FDA.report

510(k) K172141

Device
Pulse Oximeter
Applicant
Shanghai Berry Electronic Tech Co., Ltd
510(k) number
K172141
Product code
DQA  
Decision
Substantially Equivalent (SESE)
Decision date
2018-04-04
Date received
2017-07-17
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
Xuezhi Yin
Address
Unit C, 1st Floor, 7th Bldg., # 1188 Lianhang Rd. Minhang District, Shanghai CN 201112 201112

FDA Registration Numbers

Source Documents

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

Related GUDID Devices

Primary DIBrandCompanyPublished
06924054300456TeleRPMSHANGHAI BERRY ELECTRONIC TECH CO., LTD.2025-01-03
00897037001229NatureSpiritSIMPRO2019-03-29

Legacy Summary

summary

FDA Review

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