The following data is part of a premarket notification filed by Vivant Medical, Inc. with the FDA for Vivatherm Themperature Measurement System.
| Device ID | K031556 |
| 510k Number | K031556 |
| Device Name: | VIVATHERM THEMPERATURE MEASUREMENT SYSTEM |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | VIVANT MEDICAL, INC. 1916-A OLD MIDDLEFIELD WAY Mountain View, CA 94043 |
| Contact | Steven Kim |
| Correspondent | Steven Kim VIVANT MEDICAL, INC. 1916-A OLD MIDDLEFIELD WAY Mountain View, CA 94043 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-19 |
| Decision Date | 2003-06-23 |
| Summary: | summary |