The following data is part of a premarket notification filed by Ctf Systems, Inc. with the FDA for Ctf Systems Inc, Whole-cortex Meg System (with Optional Eeg Subsystem).
| Device ID | K971329 |
| 510k Number | K971329 |
| Device Name: | CTF SYSTEMS INC, WHOLE-CORTEX MEG SYSTEM (WITH OPTIONAL EEG SUBSYSTEM) |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | CTF SYSTEMS, INC. 15-1750 MCLEAN AVE. Port Coquitlam, B.c., CA V3c 1m9 |
| Contact | Stephen E Robinson |
| Correspondent | Stephen E Robinson CTF SYSTEMS, INC. 15-1750 MCLEAN AVE. Port Coquitlam, B.c., CA V3c 1m9 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-10 |
| Decision Date | 1997-11-20 |
| Summary: | summary |