510(k) K142897
K142897 is an FDA 510(k) premarket notification submitted by Optos Plc. for the device "P200DTx". The FDA issued a decision of Substantially Equivalent on January 16, 2015. The device falls under product code MYC (Ophthalmoscope, Laser, Scanning), a Class II device regulated under 21 CFR 886.1570. Optos Plc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 16, 2015
- Date Received
- October 3, 2014
- 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