MiiS Horus Scope DPT 100— 510(k) K181260
Substantially EquivalentMedimaging Integrated Solution, Inc (Miis)
FDA 510(k) clearance K181260 for MiiS Horus Scope DPT 100, Substantially Equivalent on 2019-06-21. Applicant: Medimaging Integrated Solution, Inc (Miis). Device class: 2.
Clearance details
- Applicant
- Medimaging Integrated Solution, Inc (Miis)
- Product code
- Code HKX
- Device class
- Class 2
- Regulation
- 21 CFR 886.1930
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hsinchu, CN
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