The following data is part of a premarket notification filed by Canon U.s.a., Inc. with the FDA for Canon Iol Estimator Ku-1.
Device ID | K881889 |
510k Number | K881889 |
Device Name: | CANON IOL ESTIMATOR KU-1 |
Classification | System, Imaging, Pulsed Echo, Ultrasonic |
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 | IYO |
CFR Regulation Number | 892.1560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-05-05 |
Decision Date | 1988-09-15 |