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FDA 510(k)

ECHOBRIGHT

K-Number: K111355 · 2011-09-16

ApplicantLife-Tech, Inc.
Decision Date2011-09-16
Product CodeCAZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ECHOBRIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Life-Tech, Inc.. It received FDA 510(k) clearance on 2011-09-16 under 510(k) number K111355. The device is classified under product code CAZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECHOBRIGHT?

ECHOBRIGHT is a medical device that received FDA 510(k) clearance on 2011-09-16. The listed applicant is Life-Tech, Inc.. The 510(k) number is K111355.

When did ECHOBRIGHT receive FDA 510(k) clearance?

ECHOBRIGHT received FDA 510(k) clearance on 2011-09-16, under 510(k) number K111355.

Who is the listed applicant for ECHOBRIGHT?

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

What is the FDA product code for ECHOBRIGHT?

The FDA product code for ECHOBRIGHT is CAZ.

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Other records listing Life-Tech, Inc. 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.

K120234EZONO 3000K102813EZONO 3000K102007PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC,K093662ECHOBRIGHTK093485VESISCANK082772STIMPRO, MODELS SP22050, SP20100, SPP19050, SPP19100, SPP19150, SPC19050, SPC19100, SPC19150, SPC18050,SPC18100,SPC18150

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Related Devices (Code: CAZ)

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.

K261372Profoject™ LOR SyringeCMT Health PTE., Ltd.K222341Arrow 0.2 Micron Flat Filter, GVSArrow International, LLCK210983BD Epilor SyringeBecton, Dickinson and CompanyK201356Plastic LOR SyringeJiangsu Caina Medical Co.,LtdK202699E-Cath STIM acc. TsuiPAJUNK GmbH MedizintechnologieK190345VPCPAJUNK GmbH Medizintechnologie

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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