The following data is part of a premarket notification filed by Teca, Inc. with the FDA for P460, Dg32 Electroencephalograph.
Device ID | K896666 |
510k Number | K896666 |
Device Name: | P460, DG32 ELECTROENCEPHALOGRAPH |
Classification | Full-montage Standard Electroencephalograph |
Applicant | TECA, INC. THREE CAMPUS DR. Pleasantiville, NY 10570 |
Contact | Arthur Blumenfeld |
Correspondent | Arthur Blumenfeld 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 | 1989-11-27 |
Decision Date | 1990-02-16 |