The following data is part of a premarket notification filed by Biodan Medical Systems, Ltd. with the FDA for Rtm Rehabilitation Treadmill, Model #945-200.
Device ID | K930261 |
510k Number | K930261 |
Device Name: | RTM REHABILITATION TREADMILL, MODEL #945-200 |
Classification | Treadmill, Powered |
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 | IOL |
CFR Regulation Number | 890.5380 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-01-19 |
Decision Date | 1993-05-26 |