ELEC ENGINE (Model: ISE-170L)— 510(k) K231562

Substantially Equivalent

Micro-Nx Co., Ltd.

FDA 510(k) clearance K231562 for ELEC ENGINE (Model: ISE-170L), Substantially Equivalent on 2025-07-18. Applicant: Micro-Nx Co., Ltd..

Clearance details

Applicant
Micro-Nx Co., Ltd.
Product code
Code EBW
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Daegu, KR
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