The following data is part of a premarket notification filed by Biodan Medical Systems, Ltd. with the FDA for Total Work Integrator, Model #940-110.
| Device ID | K922603 |
| 510k Number | K922603 |
| Device Name: | TOTAL WORK INTEGRATOR, MODEL #940-110 |
| Classification | Exerciser, Measuring |
| 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 | ISD |
| CFR Regulation Number | 890.5360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-02 |
| Decision Date | 1992-06-19 |