The following data is part of a premarket notification filed by Kontron Instruments, Inc. with the FDA for Kontron E.e.g. Monitor, Supermon Module 7265.
Device ID | K870815 |
510k Number | K870815 |
Device Name: | KONTRON E.E.G. MONITOR, SUPERMON MODULE 7265 |
Classification | Full-montage Standard Electroencephalograph |
Applicant | KONTRON INSTRUMENTS, INC. 9 PLYMOUTH ST. Everett, MA 02149 |
Contact | Ellen F Benedict |
Correspondent | Ellen F Benedict KONTRON INSTRUMENTS, INC. 9 PLYMOUTH ST. Everett, MA 02149 |
Product Code | GWQ |
CFR Regulation Number | 882.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-03-03 |
Decision Date | 1988-02-01 |