The following data is part of a premarket notification filed by Intelligent Medical Systems with the FDA for Firsttemp Genius.
| Device ID | K920713 |
| 510k Number | K920713 |
| Device Name: | FIRSTTEMP GENIUS |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | INTELLIGENT MEDICAL SYSTEMS 6339 PASEO DEL LAGO Carlsbad, CA 92009 |
| Contact | Gary J O'hara |
| Correspondent | Gary J O'hara INTELLIGENT MEDICAL SYSTEMS 6339 PASEO DEL LAGO Carlsbad, CA 92009 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-18 |
| Decision Date | 1992-12-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521000367 | K920713 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() FIRSTTEMP GENIUS 76490873 2812572 Dead/Cancelled |
COVIDIEN AG 2003-02-11 |