The following data is part of a premarket notification filed by Canon U.s.a., Inc. with the FDA for 60 Degree Fundus Camera, Cf-60ud.
Device ID | K934663 |
510k Number | K934663 |
Device Name: | 60 DEGREE FUNDUS CAMERA, CF-60UD |
Classification | Camera, Ophthalmic, Ac-powered |
Applicant | CANON U.S.A., INC. ONE CANON PLAZA Lake Success, NY 11042 -1198 |
Contact | Mr. Takahashi |
Correspondent | Mr. Takahashi CANON U.S.A., INC. ONE CANON PLAZA Lake Success, NY 11042 -1198 |
Product Code | HKI |
CFR Regulation Number | 886.1120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-09-28 |
Decision Date | 1994-02-22 |