MICRON-SCOPE II
FDA 510(k) clearance K926412 · decided 1994-07-19
Clearance details
- K-number
- K926412
- Device name
- MICRON-SCOPE II
- Applicant
- Chiron Vision Corp.
- Decision
- Substantially Equivalent
- Date received
- 1992-12-21
- Decision date
- 1994-07-19
- Days to decision
- 575 days
- Clearance type
- Traditional
- Product code
- HMS
- Device class
- 1
- Regulation number
- 886.4230
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.