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 |