The following data is part of a premarket notification filed by Intelligent Medical Systems with the FDA for First Temp.
| Device ID | K853713 |
| 510k Number | K853713 |
| Device Name: | FIRST TEMP |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | INTELLIGENT MEDICAL SYSTEMS 2233 FARADAY AVENUE STE.K Carlsbad, CA 92008 |
| Contact | David B Phillips |
| Correspondent | David B Phillips INTELLIGENT MEDICAL SYSTEMS 2233 FARADAY AVENUE STE.K Carlsbad, CA 92008 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-05 |
| Decision Date | 1985-11-01 |