The following data is part of a premarket notification filed by Cadi Scientific Pte.ltd with the FDA for Cadi Smartsense Vital Signs And Wireless Temperature Monitori Ng System, Model S1.
| Device ID | K083185 |
| 510k Number | K083185 |
| Device Name: | CADI SMARTSENSE VITAL SIGNS AND WIRELESS TEMPERATURE MONITORI NG SYSTEM, MODEL S1 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | CADI SCIENTIFIC PTE.LTD S65 W35739 PIPER ROAD Eagle, WI 53119 |
| Contact | Stephen H Gorski |
| Correspondent | Stephen H Gorski CADI SCIENTIFIC PTE.LTD S65 W35739 PIPER ROAD Eagle, WI 53119 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-29 |
| Decision Date | 2009-03-11 |
| Summary: | summary |