The following data is part of a premarket notification filed by Teca, Inc. with the FDA for Teca Montage Ii.
Device ID | K851232 |
510k Number | K851232 |
Device Name: | TECA MONTAGE II |
Classification | Full-montage Standard Electroencephalograph |
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 | GWQ |
CFR Regulation Number | 882.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-03-26 |
Decision Date | 1985-06-13 |