The following data is part of a premarket notification filed by Biodex Medical Systems, Inc. with the FDA for Stability System (110v) Model 945-300; Stability System (220v) Model #945-302.
| Device ID | K942694 |
| 510k Number | K942694 |
| Device Name: | STABILITY SYSTEM (110V) MODEL 945-300; STABILITY SYSTEM (220V) MODEL #945-302 |
| Classification | Platform, Force-measuring |
| Applicant | BIODEX MEDICAL SYSTEMS, INC. BROOKHAVEN R & D PLAZA 20 RAMSEY RD., P.O. BOX 702 Shirley, NY 11967 -0702 |
| Contact | Clyde Schlein |
| Correspondent | Clyde Schlein BIODEX MEDICAL SYSTEMS, INC. BROOKHAVEN R & D PLAZA 20 RAMSEY RD., P.O. BOX 702 Shirley, NY 11967 -0702 |
| Product Code | KHX |
| CFR Regulation Number | 890.1575 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-07 |
| Decision Date | 1995-03-10 |