The following data is part of a premarket notification filed by Canon U.s.a., Inc. with the FDA for Slit Lamp, H-201.
Device ID | K936209 |
510k Number | K936209 |
Device Name: | SLIT LAMP, H-201 |
Classification | Biomicroscope, Slit-lamp, Ac-powered |
Applicant | CANON U.S.A., INC. ONE CANON PLAZA Lake Success, NY 11042 -1198 |
Contact | Koichi Yano |
Correspondent | Koichi Yano CANON U.S.A., INC. ONE CANON PLAZA Lake Success, NY 11042 -1198 |
Product Code | HJO |
CFR Regulation Number | 886.1850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-12-29 |
Decision Date | 1994-04-01 |