K973592 is an FDA 510(k) clearance for the WALKCARE P200 SYSTEM. This device is classified as a Sleeve, Limb, Compressible (Class II - Special Controls, product code JOW).
Submitted by A.Stein - Regulatory Affairs Consulting (Ginot Shomron 44853, IL). The FDA issued a Cleared decision on May 20, 1999, 605 days after receiving the submission on September 22, 1997.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5800.
| 510(k) Number | K973592 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 22, 1997 |
| Decision Date | May 20, 1999 |
| Days to Decision | 605 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | JOW — Sleeve, Limb, Compressible |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5800 |