Last synced on 14 November 2025 at 11:06 pm

IS-III active System_S-narrow Type

Page Type
Cleared 510(K)
510(k) Number
K190849
510(k) Type
Traditional
Applicant
Neobiotech Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
8/14/2019
Days to Decision
135 days
Submission Type
Summary

IS-III active System_S-narrow Type

Page Type
Cleared 510(K)
510(k) Number
K190849
510(k) Type
Traditional
Applicant
Neobiotech Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
8/14/2019
Days to Decision
135 days
Submission Type
Summary