The following data is part of a premarket notification filed by Medical Systems Corp. with the FDA for Radiant Temperatur Indicator Model 25e.
| Device ID | K903501 |
| 510k Number | K903501 |
| Device Name: | RADIANT TEMPERATUR INDICATOR MODEL 25E |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | MEDICAL SYSTEMS CORP. 2805 SOUTH HWY. 89 Perry, UT 84302 |
| Contact | John D Ensign |
| Correspondent | John D Ensign MEDICAL SYSTEMS CORP. 2805 SOUTH HWY. 89 Perry, UT 84302 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-03 |
| Decision Date | 1990-09-12 |