The following data is part of a premarket notification filed by Electromedics, Inc. with the FDA for Telethermometer Model T T-100.
Device ID | K771996 |
510k Number | K771996 |
Device Name: | TELETHERMOMETER MODEL T T-100 |
Classification | Thermometer, Electronic, Clinical |
Applicant | ELECTROMEDICS, 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 | 1977-10-21 |
Decision Date | 1977-11-22 |