The following data is part of a premarket notification filed by United Hearing Systems, Inc. with the FDA for Transear Bone Conduction Hearing Aid.
| Device ID | K050653 |
| 510k Number | K050653 |
| Device Name: | TRANSEAR BONE CONDUCTION HEARING AID |
| Classification | Hearing Aid, Bone Conduction |
| Applicant | UNITED HEARING SYSTEMS, INC. 137 NORWICH RD. Central Village, CT 06332 |
| Contact | Ralph Campagna |
| Correspondent | Ralph Campagna UNITED HEARING SYSTEMS, INC. 137 NORWICH RD. Central Village, CT 06332 |
| Product Code | LXB |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-11 |
| Decision Date | 2005-07-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08103230003802 | K050653 | 000 |
| 00810323003806 | K050653 | 000 |