The following data is part of a premarket notification filed by Y with the FDA for Electronic Clinical Thermometer Temp Pr.
Device ID | K820409 |
510k Number | K820409 |
Device Name: | ELECTRONIC CLINICAL THERMOMETER TEMP PR |
Classification | Thermometer, Electronic, Clinical |
Applicant | Y 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 | 1982-02-12 |
Decision Date | 1982-03-02 |