IRIDEX WIRELESS FOOTSWITCH
FDA 510(k) clearance K062074 · decided 2006-11-14
Clearance details
- K-number
- K062074
- Device name
- IRIDEX WIRELESS FOOTSWITCH
- Applicant
- Iridex Corp
- Decision
- Substantially Equivalent
- Date received
- 2006-07-21
- Decision date
- 2006-11-14
- Days to decision
- 116 days
- Clearance type
- Traditional
- Product code
- HQF
- Device class
- 2
- Regulation number
- 886.4390
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Mountain View, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.