The following data is part of a premarket notification filed by Medisim Ltd. with the FDA for Up-grade Forehead Thermometer.
| Device ID | K032362 |
| 510k Number | K032362 |
| Device Name: | UP-GRADE FOREHEAD THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | MEDISIM LTD. THE TECHNOLOGY PARK MANHAT Jerusalem, IL 96251 |
| Contact | Dalia Givony |
| Correspondent | Dalia Givony MEDISIM LTD. THE TECHNOLOGY PARK MANHAT Jerusalem, IL 96251 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-31 |
| Decision Date | 2003-12-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20762012062714 | K032362 | 000 |
| 10845717773307 | K032362 | 000 |
| 00845717093347 | K032362 | 000 |
| 00845717093316 | K032362 | 000 |
| 10845717004166 | K032362 | 000 |
| 10713733353950 | K032362 | 000 |
| 20041415425730 | K032362 | 000 |
| 20036800478002 | K032362 | 000 |
| 00195515000406 | K032362 | 000 |
| 10846036007340 | K032362 | 000 |
| 50096295130084 | K032362 | 000 |
| 10400119854704 | K032362 | 000 |
| 10311917183494 | K032362 | 000 |
| 10311917172207 | K032362 | 000 |
| 10635515956978 | K032362 | 000 |
| 00634782563066 | K032362 | 000 |
| 00634782563059 | K032362 | 000 |
| 10713733260845 | K032362 | 000 |
| 10708820047737 | K032362 | 000 |
| 10032251921640 | K032362 | 000 |