The following data is part of a premarket notification filed by Omni Therm, Inc. with the FDA for Omni Therm Temperature Monitor.
| Device ID | K864853 |
| 510k Number | K864853 |
| Device Name: | OMNI THERM TEMPERATURE MONITOR |
| Classification | Strip, Temperature, Forehead, Liquid Crystal |
| Applicant | OMNI THERM, INC. 7919 N. BROADWAY St. Louis, MO 63147 |
| Contact | Dale E Walters |
| Correspondent | Dale E Walters OMNI THERM, INC. 7919 N. BROADWAY St. Louis, MO 63147 |
| Product Code | KPD |
| CFR Regulation Number | 880.2200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-11 |
| Decision Date | 1987-02-04 |