The following data is part of a premarket notification filed by Continental X-ray Corp. with the FDA for X-ray Equipment (various Types).
Device ID | K895730 |
510k Number | K895730 |
Device Name: | X-RAY EQUIPMENT (VARIOUS TYPES) |
Classification | System, X-ray, Fluoroscopic, Image-intensified |
Applicant | CONTINENTAL X-RAY CORP. POST OFFICE BOX 5571 Chicago, IL 60680 |
Contact | Robert D Walker |
Correspondent | Robert D Walker CONTINENTAL X-RAY CORP. POST OFFICE BOX 5571 Chicago, IL 60680 |
Product Code | JAA |
CFR Regulation Number | 892.1650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-09-22 |
Decision Date | 1989-11-06 |