K894154 is an FDA 510(k) clearance for the METABOLIC SYSTEMS. This device is classified as a Exerciser, Measuring (Class II - Special Controls, product code ISD).
Submitted by Cybex (Ronkonkoma, US). The FDA issued a Cleared decision on October 24, 1989, 132 days after receiving the submission on June 14, 1989.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5360.
| 510(k) Number | K894154 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 14, 1989 |
| Decision Date | October 24, 1989 |
| Days to Decision | 132 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | ISD — Exerciser, Measuring |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5360 |