Clearance Summary
XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059 received FDA 510(k) clearance under submission number K052112, sponsored by Excel Tech. , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2005-10-28.
- Submission: K052112
- Applicant / Sponsor: Excel Tech. , Ltd.
- Clearance pathway: Special
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.1375
- Decision date: 2005-10-28
Classification & Regulation
This clearance is catalogued under FDA product code IKN and 21 CFR 890.1375, within the Physical Medicine review panel as a Class II device.