The following data is part of a premarket notification filed by Medisim Ltd. with the FDA for Dual Mode Up-grade Forehead/underarm Thermometer Device.
| Device ID | K051422 |
| 510k Number | K051422 |
| Device Name: | DUAL MODE UP-GRADE FOREHEAD/UNDERARM THERMOMETER DEVICE |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | MEDISIM LTD. BEIT HAPA'AMON BOX 124 20 HATA'AS ST Kfar Saba, IL 44425 |
| Contact | Ahava Stein |
| Correspondent | Ahava Stein MEDISIM LTD. BEIT HAPA'AMON BOX 124 20 HATA'AS ST Kfar Saba, IL 44425 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-01 |
| Decision Date | 2005-09-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10400119854391 | K051422 | 000 |
| 10845717004173 | K051422 | 000 |