BAHA INTENSO
Hearing Aid, Bone Conduction
COCHLEAR AMERICAS
The following data is part of a premarket notification filed by Cochlear Americas with the FDA for Baha Intenso.
Pre-market Notification Details
| Device ID | K081606 |
| 510k Number | K081606 |
| Device Name: | BAHA INTENSO |
| Classification | Hearing Aid, Bone Conduction |
| Applicant | COCHLEAR AMERICAS 400 INVERNESS PARKWAY, SUITE 400 Englewood, CO 80112 |
| Contact | Sean Bundy |
| Correspondent | Sean Bundy COCHLEAR AMERICAS 400 INVERNESS PARKWAY, SUITE 400 Englewood, CO 80112 |
| Product Code | LXB |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-06 |
| Decision Date | 2008-08-28 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09321502040266 | K081606 | 000 |
Trademark Results [BAHA INTENSO]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BAHA INTENSO 79037638 3540455 Dead/Cancelled |
Cochlear Bone Anchored Solutions AB 2007-03-09 |
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