510(k) K241410

Device
EDEN ControlCath
Applicant
Jmt Co., Ltd.
510(k) number
K241410
Product code
BSO
Decision
Substantially Equivalent (SESE)
Decision date
2025-02-13
Date received
2024-05-17
Regulation
868.5120
Classification name
Catheter, Conduction, Anesthetic
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Sang-Ok Nam
Address
70-39, Gwonyul-Ro 1203beon-Gil, Baekseok-Eup Yangju-Si KR 11517 11517

FDA Registration Numbers

Source Documents

510(k) summary PDF

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