FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇳 India
AAIO-7, AAIO WIRLESS
K Number: K110205
·
Decision Feb 9, 2011
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
86
Applicant Total
2
Review Days
15
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Basic Information
- Device Name
- AAIO-7, AAIO WIRLESS
- K Number
- K110205
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1570
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Appasamy Associates
- Date Received
- January 25, 2011
- Decision Date
- February 9, 2011
- Product Code
- HLI
- 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 |
|---|---|---|---|
| HLI | Ophthalmoscope, Ac-Powered | FDA class 2 | Ophthalmic |
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Other Clearances by Appasamy Associates
| K Number | Device Name | ||
|---|---|---|---|
| K082031 | APPASAMY SLIT LAMP, A1A-11 AND A1A-12 SERIES | Jul 31, 2008 | Substantially Equivalent |