The following data is part of a premarket notification filed by Entific Medical Systems, Inc. with the FDA for Headband For Baha.
| Device ID | K002913 |
| 510k Number | K002913 |
| Device Name: | HEADBAND FOR BAHA |
| Classification | Hearing Aid, Bone Conduction |
| Applicant | ENTIFIC MEDICAL SYSTEMS, INC. 6470 RIVERVIEW TERRACE Minneapolis, MN 55432 |
| Contact | Constance G Bundy |
| Correspondent | Constance G Bundy ENTIFIC MEDICAL SYSTEMS, INC. 6470 RIVERVIEW TERRACE Minneapolis, MN 55432 |
| Product Code | LXB |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-18 |
| Decision Date | 2000-10-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09321502020671 | K002913 | 000 |