The following data is part of a premarket notification filed by Medisim Ltd. with the FDA for Temple Touch Pro (ttp) Non-invasive Temperature Monitoring System.
| Device ID | K150160 |
| 510k Number | K150160 |
| Device Name: | Temple Touch Pro (TTP) Non-invasive Temperature Monitoring System |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | MEDISIM LTD. G.G. COMMUNICATIONS CENTER Neve Ilan, IL 90850 |
| Contact | Avi Ben Yaish |
| Correspondent | Avi Ben Yaish MEDISIM LTD. G.G. COMMUNICATIONS CENTER Neve Ilan, 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 | 2015-01-23 |
| Decision Date | 2015-10-20 |
| Summary: | summary |