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
28
Registration Numbers
28
Same Product Code
48
Applicant Total
64
Review Days
235
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.
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
Ponto 5 Mini
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear 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 |
| K961728 | MIRUSCONE ABUTMENT SYSTEM | Jul 10, 1996 | Substantially Equivalent |
| K961737 | CERA ONE 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 |