The following data is part of a premarket notification filed by Ctf Systems (2001), Inc. with the FDA for Omega Whole-cortex Mfg System, Models Omega 151, Omega 275.
| Device ID | K030737 |
| 510k Number | K030737 |
| Device Name: | OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275 |
| Classification | Source Localization Software For Electroencephalograph Or Magnetoencephalograph |
| Applicant | CTF SYSTEMS (2001), INC. 15-1750 MCLEAN AVE. Port Coquitlam, B.c., CA V3c 1m9 |
| Contact | Daryl Wisdahl |
| Correspondent | Daryl Wisdahl CTF SYSTEMS (2001), INC. 15-1750 MCLEAN AVE. Port Coquitlam, B.c., CA V3c 1m9 |
| Product Code | OLX |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-10 |
| Decision Date | 2003-10-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B956CO0275110 | K030737 | 000 |