Last synced on 2 December 2022 at 11:04 pm

AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, AURIS CIC

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K971399
510(k) Type
Traditional
Applicant
GENERAL HEARING INSTRUMENTS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/13/1997
Days to Decision
59 days
Submission Type
Summary