The following data is part of a premarket notification filed by Mon-a-therm, Inc. with the FDA for Model 400 & 700 Temp. Sensor Adapters.
Device ID | K823333 |
510k Number | K823333 |
Device Name: | MODEL 400 & 700 TEMP. SENSOR ADAPTERS |
Classification | Thermometer, Electronic, Clinical |
Applicant | MON-A-THERM, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-11-08 |
Decision Date | 1983-01-12 |