XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059— 510(k) K052112

Name: FDA 510(k) clearance K052112
Creator: U.S. Food and Drug Administration
Published: 2005-10-28

Substantially Equivalent

Excel Tech. , Ltd.

FDA 510(k) clearance K052112 for XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059, Substantially Equivalent on 2005-10-28. Applicant: Excel Tech. , Ltd.. Device class: 2.

Clearance details

Applicant: Excel Tech. , Ltd.
Product code: Code IKN
Device class: Class 2
Regulation: 21 CFR 890.1375
Advisory panel: Physical Medicine
Date received: 2005-08-04
Decision date: 2005-10-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Oakville, CA

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.