K980044 is an FDA 510(k) clearance for the XENON 300MX, a Light, Surgical, Floor Standing (Class II — Special Controls, product code FSS), submitted by Perkinelmer Optoelectronics (Salem, US). The FDA issued a Cleared decision on April 3, 1998, 87 days after receiving the submission on January 6, 1998. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K980044 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 06, 1998 |
| Decision Date | April 03, 1998 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FSS — Light, Surgical, Floor Standing |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4580 |