HYDRO2, HS-75— 510(k) K000485
Substantially EquivalentInnovision, Inc.
FDA 510(k) clearance K000485 for HYDRO2, HS-75, Substantially Equivalent on 2000-05-12. Applicant: Innovision, Inc.. Device class: 2.
Clearance details
- Applicant
- Innovision, Inc.
- Product code
- Code HQD
- Device class
- Class 2
- Regulation
- 21 CFR 886.5916
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Omaha, NE, US
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