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Baha 94223

by Cochlear Bone Anchored Solutions AB

Baha 94223 is a Class II device made by Cochlear Bone Anchored Solutions AB, cleared under FDA 510(k) K132278 on 26 Sep 2013 and listed in FDA GUDID since 3 Jul 2017 (UDI-DI 09321502026383), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K132278

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number09321502026383 UDI-DI Date3 Jul 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK132278 Date26 Sep 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K132278 decided 26 Sep 2013 Active
  • FDA GUDID UDI-DI 09321502026383 listed 3 Jul 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K132278
  2. Listed FDA GUDID 09321502026383

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Baha
Generic name
Hearing aid wireless-fitting computer-aided set
Model / Ref / Catalog
94223
Primary DI / UDI-DI
09321502026383
510(k) Number
FDA product code
LXB
GMDN term
Hearing aid wireless-fitting computer-aided set
Device class
Class II
Regulation number
874.3302
GUDID distribution status
In Commercial Distribution

Related devices

Category: Hearing aid wireless-fitting computer-aided set

Cleared under the same submission (K132278)

Similar devices

Other devices filed under FDA product code LXB (Hearing aid, bone conduction).

Other devices from Cochlear Bone Anchored Solutions AB

See all devices from Cochlear Bone Anchored Solutions AB →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)