The following data is part of a premarket notification filed by Labarge, Inc. with the FDA for Mon-a-therm Temparature Monitor Sys.
Device ID | K760720 |
510k Number | K760720 |
Device Name: | MON-A-THERM TEMPARATURE MONITOR SYS |
Classification | Thermometer, Electronic, Clinical |
Applicant | LABARGE, 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 | 1976-09-27 |
Decision Date | 1976-11-30 |