OPTI-AMP DC-POWERED
FDA 510(k) clearance K052060 · decided 2005-08-31
Clearance details
- K-number
- K052060
- Device name
- OPTI-AMP DC-POWERED
- Applicant
- Intelligent Hearing Systems
- Decision
- Substantially Equivalent
- Date received
- 2005-07-29
- Decision date
- 2005-08-31
- Days to decision
- 33 days
- Clearance type
- Special
- Product code
- GWL
- Device class
- 2
- Regulation number
- 882.1835
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Miami, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.