The following data is part of a premarket notification filed by Sensortek, Inc. with the FDA for Nte-2 Thermal Sensitivity Tester.
Device ID | K864345 |
510k Number | K864345 |
Device Name: | NTE-2 THERMAL SENSITIVITY TESTER |
Classification | Test, Temperature Discrimination |
Applicant | SENSORTEK, INC. 154 HURON AVE. Clifton, NJ 07013 |
Contact | Ronald Feller |
Correspondent | Ronald Feller SENSORTEK, INC. 154 HURON AVE. Clifton, NJ 07013 |
Product Code | LQW |
CFR Regulation Number | 882.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-11-04 |
Decision Date | 1987-01-29 |