K013242 is an FDA 510(k) clearance for the AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM. This device is classified as a Lamp, Surgical (Class II - Special Controls, product code FTD).
Submitted by STERIS Corporation (Montgomery, US). The FDA issued a Cleared decision on December 13, 2001, 76 days after receiving the submission on September 28, 2001.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K013242 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 2001 |
| Decision Date | December 13, 2001 |
| Days to Decision | 76 days |
| Submission Type | Abbreviated |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FTD — Lamp, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4580 |