FDA.report

510(k) K063291

Device
INFRARED EAR THERMOMETER, MODEL IRT-21 AND IRT-22
Applicant
CHOICE SMART HEALTH CARE CO. LTD.
510(k) number
K063291
Product code
FLL  
Decision
Substantially Equivalent (SESE)
Decision date
2006-11-21
Date received
2006-11-01
Regulation
880.2910
Classification name
Thermometer, Electronic, Clinical
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
Yes
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
JANICE MA
Address
2108 Ciro'S Plz. 388 W. Nanjing Rd. Shanghai CN 200003 200003

FDA Registration Numbers

Source Documents

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

Legacy Summary

summary

FDA Review

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