The following data is part of a premarket notification filed by Teca, Inc. with the FDA for Teca 1a96, 1a97 And 1a98 Electroencephalographs.
Device ID | K890881 |
510k Number | K890881 |
Device Name: | TECA 1A96, 1A97 AND 1A98 ELECTROENCEPHALOGRAPHS |
Classification | Full-montage Standard Electroencephalograph |
Applicant | TECA, INC. THREE CAMPUS DR. Pleasantiville, NY 10570 |
Contact | Scott A Grillo |
Correspondent | Scott A Grillo 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 | 1989-02-21 |
Decision Date | 1989-03-23 |