The following data is part of a premarket notification filed by Biodan Medical Systems, Ltd. with the FDA for Cardiac Stress Table, 056-180/univ Roll Stress Att.
Device ID | K926082 |
510k Number | K926082 |
Device Name: | CARDIAC STRESS TABLE, 056-180/UNIV ROLL STRESS ATT |
Classification | System, X-ray, Angiographic |
Applicant | BIODAN MEDICAL SYSTEMS, LTD. BROOKHAVE R & D PLAZA 20 RAMSAY RD.,BOX 702 Shirley, NY 11967 |
Contact | Clyde Schlein |
Correspondent | Clyde Schlein BIODAN MEDICAL SYSTEMS, LTD. BROOKHAVE R & D PLAZA 20 RAMSAY RD.,BOX 702 Shirley, NY 11967 |
Product Code | IZI |
CFR Regulation Number | 892.1600 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-01 |
Decision Date | 1992-12-30 |