XOMED AUDIANT BONE CONDUCTOR W/IMPROVED AA COIL— 510(k) K861971
Substantially EquivalentXomed, Inc.
FDA 510(k) clearance K861971 for XOMED AUDIANT BONE CONDUCTOR W/IMPROVED AA COIL, Substantially Equivalent on 1986-05-30. Applicant: Xomed, Inc.. Device class: 2.
Clearance details
- Applicant
- Xomed, Inc.
- Product code
- Code LXB
- Device class
- Class 2
- Regulation
- 21 CFR 874.3302
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jacksonville, FL, US
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- K261256 — Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)
- K250215 — Baha 7 Sound Processor +4 more
More clearances from Xomed, Inc.
view allAdverse events under product code LXB
product code LXB- Injury
- 2,334
- Total
- 2,334
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.