OPTO GLOBAL DIGITAL FUNDUS CAMERA SYSTEM MODEL ADS 1.5— 510(k) K053044
Substantially EquivalentOpto Global, Inc.
FDA 510(k) clearance K053044 for OPTO GLOBAL DIGITAL FUNDUS CAMERA SYSTEM MODEL ADS 1.5, Substantially Equivalent on 2006-01-24. Applicant: Opto Global, Inc.. Device class: 2.
Clearance details
- Applicant
- Opto Global, Inc.
- Product code
- Code HKI
- Device class
- Class 2
- Regulation
- 21 CFR 886.1120
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Granite Bay, CA, US
Recent devices under product code HKI
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