K971390 is an FDA 510(k) clearance for the QUANTUM 3080SP SURGICAL TABLE. This device is classified as a Table, Operating-room, Electrical (Class I - General Controls, product code GDC).
Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on May 15, 1997, 31 days after receiving the submission on April 14, 1997.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4960.
| 510(k) Number | K971390 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 14, 1997 |
| Decision Date | May 15, 1997 |
| Days to Decision | 31 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GDC — Table, Operating-room, Electrical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4960 |