FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE
K Number: K984162
·
Decision Jun 28, 1999
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
10
Applicant Total
64
Review Days
221
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Basic Information
- Device Name
- BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE
- K Number
- K984162
- 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
- November 19, 1998
- Decision Date
- June 28, 1999
- Product Code
- MAH
- 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 |
|---|---|---|---|
| MAH | Hearing Aid, Bone Conduction, Implanted | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MAH), ordered by most recent decision date.
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Ponto Bone Anchored Hearing System
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BA400 14mm Abutment
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Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mm
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Other Clearances by Nobelpharma USA, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K962403 | NOBLEPHARMA WIDE ACCESSORIES | Sep 6, 1996 | Substantially Equivalent |
| K955713 | NOBELPHARMA BONE ANCHORED HEARING AID | Aug 9, 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 |