The following data is part of a premarket notification filed by Medisim Ltd. with the FDA for Up-grade And Up-grade Pro.
| Device ID | K983887 |
| 510k Number | K983887 |
| Device Name: | UP-GRADE AND UP-GRADE PRO |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | MEDISIM LTD. 555 THIRTEENTH ST, NW Washington, DC 20004 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan MEDISIM LTD. 555 THIRTEENTH ST, NW Washington, DC 20004 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-02 |
| Decision Date | 1999-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10311917167784 | K983887 | 000 |
| 00635515952249 | K983887 | 000 |
| 00634782584412 | K983887 | 000 |
| 20762012078210 | K983887 | 000 |
| 00708820985513 | K983887 | 000 |
| 10845717006634 | K983887 | 000 |
| 20036800451838 | K983887 | 000 |
| 10845717008997 | K983887 | 000 |