The following data is part of a premarket notification filed by Radiation Measurements, Inc. with the FDA for Rmi Transillumination Light Meter #295.
| Device ID | K811108 |
| 510k Number | K811108 |
| Device Name: | RMI TRANSILLUMINATION LIGHT METER #295 |
| Classification | Transilluminator, Ac-powered |
| Applicant | RADIATION MEASUREMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HJM |
| CFR Regulation Number | 886.1945 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-04-23 |
| Decision Date | 1981-07-01 |