510(k) K072259
K072259 is an FDA 510(k) premarket notification submitted by Nidek Co., Ltd. for the device "OPHTHALMOSCOPE F-10". The FDA issued a decision of Substantially Equivalent on May 6, 2008. The device falls under product code MYC (Ophthalmoscope, Laser, Scanning), a Class II device regulated under 21 CFR 886.1570. Nidek Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 6, 2008
- Date Received
- August 14, 2007
- Clearance Type
- Abbreviated
- 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