The following data is part of a premarket notification filed by Medisim Ltd. with the FDA for Ugft3; Fht7.
| Device ID | K131155 |
| 510k Number | K131155 |
| Device Name: | UGFT3; FHT7 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | MEDISIM LTD. G.G. COMMUNICATIONS CENTER NEVE IIAN Jerusalem, IL 90850 |
| Contact | Moshe Yarden |
| Correspondent | Moshe Yarden MEDISIM LTD. G.G. COMMUNICATIONS CENTER NEVE IIAN Jerusalem, IL 90850 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-24 |
| Decision Date | 2013-08-28 |
| Summary: | summary |