FDA.report

510(k) K122410

Device
I RUNE (I-200L)
Applicant
MEDIRUNE CO, LTD
510(k) number
K122410
Product code
NUH  
Decision
Substantially Equivalent (SESE)
Decision date
2013-11-12
Date received
2012-08-08
Regulation
882.5890
Classification name
Stimulator, Nerve, Transcutaneous, Over-the-counter
Medical specialty
Neurology
Review panel
Neurology
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
YANG HO DONG
Address
#821 Samil Plz., 837-26 Yeuksam-Dong Gangnam-Gu KR 135-768 135-768

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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