The following data is part of a premarket notification filed by Good-lite Co. with the FDA for Hi-lo Floor Standing Exam. Light.
| Device ID | K842135 |
| 510k Number | K842135 |
| Device Name: | HI-LO FLOOR STANDING EXAM. LIGHT |
| Classification | Device, Medical Examination, Ac Powered |
| Applicant | GOOD-LITE CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KZF |
| CFR Regulation Number | 880.6320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-30 |
| Decision Date | 1984-07-06 |