The following data is part of a premarket notification filed by Teca, Inc. with the FDA for Teca/medelec As-10 Sensor.
Device ID | K862906 |
510k Number | K862906 |
Device Name: | TECA/MEDELEC AS-10 SENSOR |
Classification | Stimulator, Auditory, Evoked Response |
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 | GWJ |
CFR Regulation Number | 882.1900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-07-31 |
Decision Date | 1987-02-04 |