The following data is part of a premarket notification filed by Medisim Ltd. with the FDA for Non-invasive Infrared (nir).
| Device ID | K090386 |
| 510k Number | K090386 |
| Device Name: | NON-INVASIVE INFRARED (NIR) |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | MEDISIM LTD. G.G. COMMUNICATIONS CENTER Neve Ilan, IL 90850 |
| Contact | Yevgenia Libster |
| Correspondent | Yevgenia Libster 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 | 2009-02-17 |
| Decision Date | 2010-05-28 |
| Summary: | summary |