The following data is part of a premarket notification filed by Xerox Medical Systems with the FDA for Xerox 128 Cassette Changer.
Device ID | K812024 |
510k Number | K812024 |
Device Name: | XEROX 128 CASSETTE CHANGER |
Classification | Changer, Radiographic Film/cassette |
Applicant | XEROX MEDICAL SYSTEMS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KPX |
CFR Regulation Number | 892.1860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-07-20 |
Decision Date | 1981-08-13 |