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FDA 510(k)

MYLAB40

K-Number: K070903 · 2007-07-02

ApplicantEsaote Europe B.V.
Decision Date2007-07-02
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MYLAB40 is the device name listed in this FDA 510(k) record. The listed applicant is Esaote Europe B.V.. It received FDA 510(k) clearance on 2007-07-02 under 510(k) number K070903. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MYLAB40?

MYLAB40 is a medical device that received FDA 510(k) clearance on 2007-07-02. The listed applicant is Esaote Europe B.V.. The 510(k) number is K070903.

When did MYLAB40 receive FDA 510(k) clearance?

MYLAB40 received FDA 510(k) clearance on 2007-07-02, under 510(k) number K070903.

Who is the listed applicant for MYLAB40?

The FDA 510(k) record lists Esaote Europe B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MYLAB40?

The FDA product code for MYLAB40 is ITX.

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Other records listing Esaote Europe B.V. 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.

K161168MyLabSix Ultrasound SystemK101605MYLABONE ULTRASOUND SYSTEMK083882MYLABFIVEK062598IMT.LAB SOFTWAREK061755MYLAB15/20 NEW INDICATIONS ULTRASOUND SYSTEM

Related Devices (Code: ITX)

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.

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna 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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