The following data is part of a premarket notification filed by Biodan Medical Systems, Ltd. with the FDA for Trendelenburg Ultrasound Table, Model # 056-603.
Device ID | K922605 |
510k Number | K922605 |
Device Name: | TRENDELENBURG ULTRASOUND TABLE, MODEL # 056-603 |
Classification | System, Imaging, Pulsed Echo, Ultrasonic |
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 | IYO |
CFR Regulation Number | 892.1560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-06-02 |
Decision Date | 1992-10-20 |