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 |