ELEC ENGINE (Model: ISE-170L)
K-Number: K231562 · 2025-07-18
ApplicantMicro-Nx Co., Ltd.
Decision Date2025-07-18
Product CodeEBW
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
ELEC ENGINE (Model: ISE-170L) is a medical device manufactured by Micro-Nx Co., Ltd.. It received FDA 510(k) clearance on 2025-07-18 under approval number K231562. The device is classified under product code EBW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ELEC ENGINE (Model: ISE-170L)?
ELEC ENGINE (Model: ISE-170L) is a medical device that received FDA 510(k) clearance on 2025-07-18. It is manufactured by Micro-Nx Co., Ltd.. The 510(k) number is K231562.
When was ELEC ENGINE (Model: ISE-170L) approved by the FDA?
ELEC ENGINE (Model: ISE-170L) received FDA 510(k) clearance on 2025-07-18, under approval number K231562.
What company makes ELEC ENGINE (Model: ISE-170L)?
ELEC ENGINE (Model: ISE-170L) is manufactured by Micro-Nx Co., Ltd..
What is the FDA product code for ELEC ENGINE (Model: ISE-170L)?
The FDA product code for ELEC ENGINE (Model: ISE-170L) is EBW.
Other Devices by Micro-Nx Co., Ltd.
Related Devices (Code: EBW)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.