The following data is part of a premarket notification filed by Excel Tech. Ltd. with the FDA for Xltek Xcalibur Emg / Lt, Model Pk1p33, Pk1059.
| Device ID | K052112 |
| 510k Number | K052112 |
| Device Name: | XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059 |
| Classification | Electromyograph, Diagnostic |
| 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 | IKN |
| CFR Regulation Number | 890.1375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-04 |
| Decision Date | 2005-10-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830041928 | K052112 | 000 |
| 00382830003155 | K052112 | 000 |
| 00382830003063 | K052112 | 000 |
| 00382830002950 | K052112 | 000 |
| 00382830002424 | K052112 | 000 |