FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
MIRA Adapter
K Number: K200911
·
Decision Jun 2, 2020
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
9
Applicant Total
4
Review Days
57
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Basic Information
- Device Name
- MIRA Adapter
- K Number
- K200911
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4170
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Phakos
- Date Received
- April 6, 2020
- Decision Date
- June 2, 2020
- Product Code
- HRN
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HRN | Unit, Cryophthalmic, Ac-Powered | FDA class 2 | Ophthalmic |
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