The following data is part of a premarket notification filed by Cochlear Americas with the FDA for Baha Intenso.
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 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
09321502040266 | K081606 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() BAHA INTENSO 79037638 3540455 Dead/Cancelled |
Cochlear Bone Anchored Solutions AB 2007-03-09 |