The following data is part of a premarket notification filed by Teca, Inc. with the FDA for Teca/medelec Ttt Thermal Threshold Tester.
Device ID | K872931 |
510k Number | K872931 |
Device Name: | TECA/MEDELEC TTT THERMAL THRESHOLD TESTER |
Classification | Device, Vibration Threshold Measurement |
Applicant | TECA, INC. THREE CAMPUS DR. Pleasantiville, NY 10570 |
Contact | Edward R Sirois |
Correspondent | Edward R Sirois TECA, INC. THREE CAMPUS DR. Pleasantiville, NY 10570 |
Product Code | LLN |
CFR Regulation Number | 882.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-07-27 |
Decision Date | 1987-11-16 |