K953071 is an FDA 510(k) clearance for the STRYKER COMMAND2 OFFICE CONSOLE. This device is classified as a Table, Surgical With Orthopedic Accessories, Ac-powered (Class I - General Controls, product code JEA).
Submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on August 8, 1995, 39 days after receiving the submission on June 30, 1995.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4960.
| 510(k) Number | K953071 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 30, 1995 |
| Decision Date | August 08, 1995 |
| Days to Decision | 39 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | JEA — Table, Surgical With Orthopedic Accessories, Ac-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4960 |