FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NOBELPHARMA BONE ANCHORED HEARING AID
K Number: K955713
·
Decision Aug 9, 1996
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
50
Applicant Total
64
Review Days
235
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- NOBELPHARMA BONE ANCHORED HEARING AID
- K Number
- K955713
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3302
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nobelpharma USA, Inc.
- Date Received
- December 18, 1995
- Decision Date
- August 9, 1996
- Product Code
- LXB
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LXB | Hearing Aid, Bone Conduction | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LXB), ordered by most recent decision date.
Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153, G42154, G42155, G42156, G42157, G42158, G42159, G42160, G43151, G43152, G43153, G43154, G43155, G43156, G45151, G45152, G45153, G45154, G45155, G45156, G45157, G45158, G45159, G45160, G46151, G46152, G46153, G46154, G46155, G46156, G46157, G46158)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
contact forte Alpha
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Ponto 5 SuperPower
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Other Clearances by Nobelpharma USA, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K984162 | BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE | Jun 28, 1999 | Substantially Equivalent |
| K962403 | NOBLEPHARMA WIDE ACCESSORIES | Sep 6, 1996 | Substantially Equivalent |
| K962130 | BRANEMARK SYSTEMS MKII SELK-TAPPING FIXTURE | Jul 22, 1996 | Substantially Equivalent |
| K961736 | 17 ANGULATED ABUTMENT | Jul 18, 1996 | Substantially Equivalent |
| K961737 | CERA ONE ABUTMENT SYSTEM | Jul 10, 1996 | Substantially Equivalent |
| K961728 | MIRUSCONE ABUTMENT SYSTEM | Jul 10, 1996 | Substantially Equivalent |
| K960639 | ABUTMENT SELECTION KIT | May 14, 1996 | Substantially Equivalent |
| K955697 | ABUTMENT RETRIEVAL KIT | Jan 30, 1996 | Substantially Equivalent |
| K955372 | BALL ATTACHMENT SYSTEM | Jan 23, 1996 | Substantially Equivalent |
| K953435 | BRANEMARK RADIOGRAPHIC DEPTH GUAGE | Oct 3, 1995 | Substantially Equivalent |