The following data is part of a premarket notification filed by Teca, Inc. with the FDA for Ee1114, 1118, 1121 Electro-encephalograph.
Device ID | K903004 |
510k Number | K903004 |
Device Name: | EE1114, 1118, 1121 ELECTRO-ENCEPHALOGRAPH |
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 | 1990-07-09 |
Decision Date | 1990-11-15 |