The following data is part of a premarket notification filed by Perkinelmer Optoelectronics with the FDA for Xenon 300mx.
| Device ID | K980044 |
| 510k Number | K980044 |
| Device Name: | XENON 300MX |
| Classification | Light, Surgical, Floor Standing |
| Applicant | PERKINELMER OPTOELECTRONICS 35 CONGRESS ST. Salem, MA 01970 |
| Contact | Anthony Statuto |
| Correspondent | Anthony Statuto PERKINELMER OPTOELECTRONICS 35 CONGRESS ST. Salem, MA 01970 |
| Product Code | FSS |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-06 |
| Decision Date | 1998-04-03 |
| Summary: | summary |