The following data is part of a premarket notification filed by Canon U.s.a., Inc. with the FDA for Canon Auto Acuitometer Cv-10.
Device ID | K861416 |
510k Number | K861416 |
Device Name: | CANON AUTO ACUITOMETER CV-10 |
Classification | Chart, Visual Acuity |
Applicant | CANON U.S.A., INC. ONE JERICHO PLAZA Jericho, NY 11753 -1000 |
Contact | Tamada |
Correspondent | Tamada CANON U.S.A., INC. ONE JERICHO PLAZA Jericho, NY 11753 -1000 |
Product Code | HOX |
CFR Regulation Number | 886.1150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-04-15 |
Decision Date | 1986-05-14 |