AAIO-7, Aaio Wirless
FDA 510(k) K110205 · Appasamy Associates
510(k) numberK110205
Submission
- Device name
- AAIO-7, Aaio Wirless
- Applicant
- Appasamy Associates
Arumbakkam, Chennai, IN - Received
- January 25, 2011
- Decision date
- February 9, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
- Third-party review
- Yes
Device classification
- Product code
- HLI – Ophthalmoscope, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1570
- Specialty
- Ophthalmic
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Questions and answers
When was AAIO-7, Aaio Wirless cleared by the FDA?
AAIO-7, Aaio Wirless (K110205) received a 510(k) decision of Substantially Equivalent on February 9, 2011, 15 days after the submission was received.
What is the product code of K110205?
The FDA product code is HLI – Ophthalmoscope, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1570.