510(k) K872111
K872111 is an FDA 510(k) premarket notification submitted by Orthotone Corp. for the device "ORTHOTONE". The FDA issued a decision of Substantially Equivalent on November 16, 1988. The device falls under product code HLL (Monitor, Eye Movement), a Class II device regulated under 21 CFR 886.1510.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 16, 1988
- Date Received
- June 1, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Eye Movement
- Device Class
- Class II
- Regulation Number
- 886.1510
- Review Panel
- OP
- Submission Type