510(k) K991284
K991284 is an FDA 510(k) premarket notification submitted by Nidek, Inc. for the device "ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM". The FDA issued a decision of Substantially Equivalent on August 6, 1999. The device falls under product code MXK (Device, Analysis, Anterior Segment), a Class II device regulated under 21 CFR 886.1850. Nidek, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 6, 1999
- Date Received
- April 15, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Analysis, Anterior Segment
- Device Class
- Class II
- Regulation Number
- 886.1850
- Review Panel
- OP
- Submission Type