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FDA 510(k)

XLTEK CONNEX IP HEADBOX, MODEL 1054

K-Number: K042223 · 2004-09-16

ApplicantExcel Tech. , Ltd.
Decision Date2004-09-16
Product CodeOMB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

XLTEK CONNEX IP HEADBOX, MODEL 1054 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 2004-09-16 under 510(k) number K042223. The device is classified under product code OMB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XLTEK CONNEX IP HEADBOX, MODEL 1054?

XLTEK CONNEX IP HEADBOX, MODEL 1054 is a medical device that received FDA 510(k) clearance on 2004-09-16. The listed applicant is Excel Tech. , Ltd.. The 510(k) number is K042223.

When did XLTEK CONNEX IP HEADBOX, MODEL 1054 receive FDA 510(k) clearance?

XLTEK CONNEX IP HEADBOX, MODEL 1054 received FDA 510(k) clearance on 2004-09-16, under 510(k) number K042223.

Who is the listed applicant for XLTEK CONNEX IP HEADBOX, MODEL 1054?

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 CONNEX IP HEADBOX, MODEL 1054?

The FDA product code for XLTEK CONNEX IP HEADBOX, MODEL 1054 is OMB.

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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 PK1070K052112XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059K052111XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382

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Related Devices (Code: OMB)

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.

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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.

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