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FDA 510(k)

ICTA

K-Number: K120260 · 2012-06-29

ApplicantExcel-Tech Ltd. (Xltek)
Decision Date2012-06-29
Product CodeOMB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ICTA is the device name listed in this FDA 510(k) record. The listed applicant is Excel-Tech Ltd. (Xltek). It received FDA 510(k) clearance on 2012-06-29 under 510(k) number K120260. 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 ICTA?

ICTA is a medical device that received FDA 510(k) clearance on 2012-06-29. The listed applicant is Excel-Tech Ltd. (Xltek). The 510(k) number is K120260.

When did ICTA receive FDA 510(k) clearance?

ICTA received FDA 510(k) clearance on 2012-06-29, under 510(k) number K120260.

Who is the listed applicant for ICTA?

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

What is the FDA product code for ICTA?

The FDA product code for ICTA is OMB.

Other records listing Excel-Tech Ltd. (Xltek) 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.

K123079OLYMPIC BRAINZ MONITORK090277NATUS SLEEPWORKS, MODEL 104017K100126STELLATE GRIDVIEWK081741NEUROLINK IP, MODEL PK1113

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.

K260998Ceribell Neurology Review SoftwareCeribell, Inc.K252070Ceribell Infant Seizure Detection SoftwareCeribell, Inc.K252160Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))Persyst Development, LLCK241589Ceribell Seizure Detection SoftwareCeribell, Inc.K243743autoSCORE (V 2.0.0)Holberg Eeg ASK242446Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))Persyst Development Corporation

Official Source

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

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