The following data is part of a premarket notification filed by Excel Tech. Ltd. with the FDA for Xltek Connex Ip Headbox, Model 1054.
| Device ID | K042223 |
| 510k Number | K042223 |
| Device Name: | XLTEK CONNEX IP HEADBOX, MODEL 1054 |
| Classification | Automatic Event Detection Software For Full-montage Electroencephalograph |
| Applicant | EXCEL TECH. LTD. 2568 BRISTOL CIRCLE Oakville, Ontario, CA L6h 5s1 |
| Contact | Nicole Landreville |
| Correspondent | Nicole Landreville EXCEL TECH. LTD. 2568 BRISTOL CIRCLE Oakville, Ontario, CA L6h 5s1 |
| Product Code | OMB |
| Subsequent Product Code | OLT |
| Subsequent Product Code | OLV |
| Subsequent Product Code | OLZ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-17 |
| Decision Date | 2004-09-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830016643 | K042223 | 000 |
| 00382830009072 | K042223 | 000 |
| 00382830002820 | K042223 | 000 |
| 00382830002554 | K042223 | 000 |
| 00382830002547 | K042223 | 000 |
| 00382830002523 | K042223 | 000 |
| 00382830002516 | K042223 | 000 |
| 00382830002493 | K042223 | 000 |