Device Classification Name |
tester, auditory impedance
|
510(k) Number |
K183201 |
Device Name |
Hearing Healthcare Pro |
Applicant |
dB Diagnostic Systems, Inc. |
17 Sachem Road |
Weston,
CT
06883
|
|
Applicant Contact |
Steven Levine |
Correspondent |
MEDIcept, Inc. |
200 Homer Avenue |
Ashland,
MA
01721
|
|
Correspondent Contact |
Scott Blood |
Regulation Number | 874.1090
|
Classification Product Code |
|
Date Received | 11/19/2018 |
Decision Date | 03/06/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|