The following data is part of a premarket notification filed by Coherent Medical Division with the FDA for The Ocuplot D.
Device ID | K822415 |
510k Number | K822415 |
Device Name: | THE OCUPLOT D |
Classification | Instrument, Visual Field, Laser |
Applicant | COHERENT MEDICAL DIVISION 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HPJ |
CFR Regulation Number | 886.1360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-08-11 |
Decision Date | 1982-09-07 |