The following data is part of a premarket notification filed by Biodex Corp. with the FDA for Biodex Lift Simulator.
Device ID | K900450 |
510k Number | K900450 |
Device Name: | BIODEX LIFT SIMULATOR |
Classification | System, Isokinetic Testing And Evaluation |
Applicant | BIODEX CORP. 20 RAMSAY RD. P.O. BOX 702 Shirley, NY 11967 |
Contact | James Reiss |
Correspondent | James Reiss BIODEX CORP. 20 RAMSAY RD. P.O. BOX 702 Shirley, NY 11967 |
Product Code | IKK |
CFR Regulation Number | 890.1925 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-01-30 |
Decision Date | 1990-07-24 |