Last synced on 14 November 2025 at 11:06 pm

IT-III active System

Page Type
Cleared 510(K)
510(k) Number
K181137
510(k) Type
Traditional
Applicant
Neobiotech Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
11/16/2018
Days to Decision
200 days
Submission Type
Summary

IT-III active System

Page Type
Cleared 510(K)
510(k) Number
K181137
510(k) Type
Traditional
Applicant
Neobiotech Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
11/16/2018
Days to Decision
200 days
Submission Type
Summary