The following data is part of a premarket notification filed by Excel Tech. Ltd. with the FDA for Xltek Emu40 Eeg Headbox, Model Pk1072.
| Device ID | K053386 |
| 510k Number | K053386 |
| Device Name: | XLTEK EMU40 EEG HEADBOX, MODEL PK1072 |
| Classification | Full-montage Standard 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 | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-05 |
| Decision Date | 2006-04-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830043762 | K053386 | 000 |
| 00382830062480 | K053386 | 000 |
| 00382830000116 | K053386 | 000 |
| 00382830000123 | K053386 | 000 |
| 00382830007047 | K053386 | 000 |
| 00382830007313 | K053386 | 000 |
| 00382830009171 | K053386 | 000 |
| 00382830011280 | K053386 | 000 |
| 00382830011297 | K053386 | 000 |
| 00382830048460 | K053386 | 000 |