Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059

K-Number: K052112 · 2005-10-28

ApplicantExcel Tech. , Ltd.
Decision Date2005-10-28
Product CodeIKN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059 is the device name listed in this FDA 510(k) record. The listed applicant is Excel Tech. , Ltd.. It received FDA 510(k) clearance on 2005-10-28 under 510(k) number K052112. The device is classified under product code IKN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059?

XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059 is a medical device that received FDA 510(k) clearance on 2005-10-28. The listed applicant is Excel Tech. , Ltd.. The 510(k) number is K052112.

When did XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059 receive FDA 510(k) clearance?

XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059 received FDA 510(k) clearance on 2005-10-28, under 510(k) number K052112.

Who is the listed applicant for XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059?

The FDA 510(k) record lists Excel Tech. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059?

The FDA product code for XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059 is IKN.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Excel Tech. , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K062549XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 105238K061269XLTEK CLEAN SIGNAL ADHESIVE ELECTRODESK053386XLTEK EMU40 EEG HEADBOX, MODEL PK1072K053058XLTEK NEUROPATH, MODEL PK1070K052111XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382K042223XLTEK CONNEX IP HEADBOX, MODEL 1054

View all 58 devices →

Related Devices (Code: IKN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K172743Natus VikingQuestNatus Neurology IncorporatedK163150ViMove2Dorsavi, Ltd.K162383Cadwell Sierra Summit, Cadwell Sierra AscentCadwell Industries, Inc.K123902PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)Oktx, LLCK123399MYOVISION 3.0 WIREFREE SYSTEMPrecision Biometrics, Inc.K113074CMAP PROMedical Technologies, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑