The following data is part of a premarket notification filed by Canon U.s.a., Inc. with the FDA for Universal Stand For Film Changer.
Device ID | K862575 |
510k Number | K862575 |
Device Name: | UNIVERSAL STAND FOR FILM CHANGER |
Classification | Changer, Radiographic Film/cassette |
Applicant | CANON U.S.A., INC. ONE JERICHO PLAZA Jericho, NY 11753 -1000 |
Contact | Mr. M Tamada |
Correspondent | Mr. M Tamada CANON U.S.A., INC. ONE JERICHO PLAZA Jericho, NY 11753 -1000 |
Product Code | KPX |
CFR Regulation Number | 892.1860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-07-07 |
Decision Date | 1986-07-14 |