The following data is part of a premarket notification filed by Sensortek, Inc. with the FDA for Thermocouple Sensors, Access. For Electronic Therm.
Device ID | K844056 |
510k Number | K844056 |
Device Name: | THERMOCOUPLE SENSORS, ACCESS. FOR ELECTRONIC THERM |
Classification | Thermometer, Electronic, Clinical |
Applicant | SENSORTEK, INC. 154 HURON AVE. Clifton, NJ 07013 |
Contact | Ronald R Feller |
Correspondent | Ronald R Feller SENSORTEK, INC. 154 HURON AVE. Clifton, NJ 07013 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-10-18 |
Decision Date | 1985-01-09 |