The following data is part of a premarket notification filed by Medisim Ltd. with the FDA for M5t Instant Fever Thermometer.
| Device ID | K012217 |
| 510k Number | K012217 |
| Device Name: | M5T INSTANT FEVER THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | MEDISIM LTD. 117 AHUZAH ST. Ra'ananna, IL |
| Contact | Shoshana Friedman |
| Correspondent | Shoshana Friedman MEDISIM LTD. 117 AHUZAH ST. Ra'ananna, IL |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-16 |
| Decision Date | 2001-08-01 |
| Summary: | summary |