The following data is part of a premarket notification filed by Endomedix with the FDA for S1500 Xenon Light Source.
| Device ID | K922837 |
| 510k Number | K922837 |
| Device Name: | S1500 XENON LIGHT SOURCE |
| Classification | Illuminator, Fiberoptic, Surgical Field |
| Applicant | ENDOMEDIX 2162 MICHELSON DR. Irvine, CA 92715 -1304 |
| Contact | Leigh Weintraub |
| Correspondent | Leigh Weintraub ENDOMEDIX 2162 MICHELSON DR. Irvine, CA 92715 -1304 |
| Product Code | HBI |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-12 |
| Decision Date | 1992-11-03 |