FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇮 Finland
OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1
K Number: K110986
·
Decision May 16, 2011
Classifications
1
FEI Numbers
65
Registration Numbers
66
Same Product Code
155
Applicant Total
5
Review Days
38
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Basic Information
- Device Name
- OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1
- K Number
- K110986
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1120
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Optomed OY
- Date Received
- April 8, 2011
- Decision Date
- May 16, 2011
- Product Code
- HKI
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HKI | Camera, Ophthalmic, Ac-Powered | FDA class 2 | Ophthalmic |
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Other Clearances by Optomed OY
| K Number | Device Name | ||
|---|---|---|---|
| K180378 | Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module | Apr 5, 2018 | Substantially Equivalent |
| K163021 | HAAG-STREIT FUNDUS MODULE 300 | Apr 11, 2017 | Substantially Equivalent |
| K132186 | OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2 | Dec 18, 2013 | Substantially Equivalent |
| K092056 | OPTOMED SMARTSCOPE, MODEL M3-1 EY1 | Oct 1, 2009 | Substantially Equivalent |