510(k) K233288

NLZ Built-In Motor System by Nakanishi, Inc. — Product Code EBW

K233288 is an FDA 510(k) premarket notification submitted by Nakanishi, Inc. for the device "NLZ Built-In Motor System". The FDA issued a decision of Substantially Equivalent on June 24, 2024. The device falls under product code EBW (Controller, Foot, Handpiece And Cord), a Class I device regulated under 21 CFR 872.4200. Nakanishi, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 2024
Date Received
September 29, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Controller, Foot, Handpiece And Cord
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type