510(k) K822415
K822415 is an FDA 510(k) premarket notification submitted by Coherent Medical Division for the device "THE OCUPLOT D". The FDA issued a decision of Substantially Equivalent on September 7, 1982. The device falls under product code HPJ (Instrument, Visual Field, Laser), a Class II device regulated under 21 CFR 886.1360. Coherent Medical Division has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 7, 1982
- Date Received
- August 11, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Visual Field, Laser
- Device Class
- Class II
- Regulation Number
- 886.1360
- Review Panel
- OP
- Submission Type