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 | K183201 |
| 510k Number | K183201 |
| Device Name: | Hearing Healthcare Pro |
| Classification | Tester, Auditory Impedance |
| Applicant | dB Diagnostic Systems, Inc. 17 Sachem Road Weston, CT 06883 |
| Contact | Steven Levine |
| Correspondent | Scott Blood 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 | 2018-11-19 |
| Decision Date | 2019-03-06 |
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 |
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