FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
XOMED AUDIANT BONE CONDUCTOR W/IMPROVED AA COIL
K Number: K861971
·
Decision May 30, 1986
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
50
Applicant Total
82
Review Days
9
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Basic Information
- Device Name
- XOMED AUDIANT BONE CONDUCTOR W/IMPROVED AA COIL
- K Number
- K861971
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3302
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Xomed, Inc.
- Date Received
- May 21, 1986
- Decision Date
- May 30, 1986
- 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
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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
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FDA 510(k)
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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 Xomed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K002395 | MODEL 30 CLASSIC PNEUMATONOMETER | Dec 11, 2000 | Substantially Equivalent |
| K002987 | REDTRONIC XOMED MONOPOLAR ENERGIZED BLADE | Dec 4, 2000 | Substantially Equivalent |
| K002828 | XPS NITRO SYSTEM | Oct 17, 2000 | Substantially Equivalent |
| K002897 | TITANIUM MIDDLE EAR PROSTHESES | Oct 11, 2000 | Substantially Equivalent |
| K993653 | MICRO-FRANCE TROCARS AND ACCESSORIES | Jun 9, 2000 | Substantially Equivalent |
| K001148 | MEROGEL OTOLOGIC PACK | Jun 3, 2000 | Substantially Equivalent |
| K994262 | FRONTAL SINUS TREPHINATION CANNULA | Feb 8, 2000 | Substantially Equivalent |
| K992855 | XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWERSCULPT | Jan 21, 2000 | Substantially Equivalent |
| K993582 | MODIFICATION TO LASER-SHIELD II | Jan 20, 2000 | Substantially Equivalent |
| K993655 | MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS | Dec 21, 1999 | Substantially Equivalent |