Last synced on 12 April 2024 at 11:04 pm

SmartEP

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K163326
510(k) Type
Traditional
Applicant
INTELLIGENT HEARING SYSTEMS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/29/2017
Days to Decision
305 days
Submission Type
Summary

SmartEP

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K163326
510(k) Type
Traditional
Applicant
INTELLIGENT HEARING SYSTEMS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/29/2017
Days to Decision
305 days
Submission Type
Summary