510(k) K153181
K153181 is an FDA 510(k) premarket notification submitted by Centervue S.P.A. for the device "MAIA". The FDA issued a decision of Substantially Equivalent on June 8, 2016. The device falls under product code MYC (Ophthalmoscope, Laser, Scanning), a Class II device regulated under 21 CFR 886.1570. Centervue S.P.A. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 8, 2016
- Date Received
- November 3, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ophthalmoscope, Laser, Scanning
- Device Class
- Class II
- Regulation Number
- 886.1570
- Review Panel
- OP
- Submission Type