Hearing Healthcare Pro
Tester, Auditory Impedance
DB Diagnostic Systems, Inc.
The following data is part of a premarket notification filed by Db Diagnostic Systems, Inc. with the FDA for Hearing Healthcare Pro.
Pre-market Notification Details
| Device ID | K171038 |
| 510k Number | K171038 |
| Device Name: | Hearing Healthcare Pro |
| Classification | Tester, Auditory Impedance |
| Applicant | dB Diagnostic Systems, Inc. 17 Sachem Road Weston, CT 06883 |
| Contact | Steven Levine |
| Correspondent | Robyn Kressin MEDIcept, Inc. 200 Homer Avenue Ashland, MA 01721 |
| Product Code | ETY |
| CFR Regulation Number | 874.1090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-06 |
| Decision Date | 2017-08-02 |
| Summary: | summary |
Trademark Results [Hearing Healthcare Pro]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HEARING HEALTHCARE PRO 98504837 not registered Live/Pending |
dB Diagnostic Systems, Inc. 2024-04-17 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.