K942694 is an FDA 510(k) clearance for the STABILITY SYSTEM (110V) MODEL 945-300; STABILITY SYSTEM (220V) MODEL #945-302. This device is classified as a Platform, Force-measuring (Class I - General Controls, product code KHX).
Submitted by Biodex Medical Systems, Inc. (Shirley, US). The FDA issued a Cleared decision on March 10, 1995, 276 days after receiving the submission on June 7, 1994.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.1575.
| 510(k) Number | K942694 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 1994 |
| Decision Date | March 10, 1995 |
| Days to Decision | 276 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | KHX — Platform, Force-measuring |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.1575 |