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FDA 510(k)

VIVASIGHT-DL SYSTEM

K-Number: K123853 · 2013-04-15

ApplicantEtview , Ltd.
Decision Date2013-04-15
Product CodeCBI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VIVASIGHT-DL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Etview , Ltd.. It received FDA 510(k) clearance on 2013-04-15 under 510(k) number K123853. The device is classified under product code CBI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIVASIGHT-DL SYSTEM?

VIVASIGHT-DL SYSTEM is a medical device that received FDA 510(k) clearance on 2013-04-15. The listed applicant is Etview , Ltd.. The 510(k) number is K123853.

When did VIVASIGHT-DL SYSTEM receive FDA 510(k) clearance?

VIVASIGHT-DL SYSTEM received FDA 510(k) clearance on 2013-04-15, under 510(k) number K123853.

Who is the listed applicant for VIVASIGHT-DL SYSTEM?

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

What is the FDA product code for VIVASIGHT-DL SYSTEM?

The FDA product code for VIVASIGHT-DL SYSTEM is CBI.

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Other records listing Etview , 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.

K181880VivaSight-SL (TVT) systemK181886VivaSight-DL SystemK152438ETView VivaSight-SL (TVT) systemK121028ETVIEW TRACHEOSCOPIC VENTILATION TUBE (TVT(TM))K120334VIVA EBK113576DOUBLE LUMEN VIDEO TRACHEOSDOPE (DLVT) SYSTEM

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Related Devices (Code: CBI)

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.

K251950Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107); Endobronchial Blocker Tube (EBT0105); Endobronchial Blocker Tube (EBT0109S); Endobronchial Blocker Tube (EBT0107S); Endobronchial Blocker Tube (EBT0105S); Endobronchial Blocker Tube (EBT0209); Endobronchial Blocker Tube (EBT0207); Endobronchial Blocker Tube (EBT0205); Endobronchial Blocker Tube (EBT0209S); Endobronchial Blocker Tube (EBT0207S); Endobronchial Blocker Tube (EBT0205S)Hangzhou Tappa Medical Technology Co., Ltd.K253096Chartis Precision CatheterPulmonx CorporationK232529Disposable Double Lumen Endobronchial TubeShenzhen Insighters Medical Technology Co., Ltd.K232580Disposable Endobronchial Blocker TubeShenzhen Insighters Medical Technology Co., Ltd.K222340Chartis Precision CatheterPulmonx CorporationK201026sOLVe TubeHytek Medical, 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.

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