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FDA 510(k)

MYLABONE ULTRASOUND SYSTEM

K-Number: K101605 · 2010-08-31

ApplicantEsaote Europe B.V.
Decision Date2010-08-31
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MYLABONE ULTRASOUND SYSTEM 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 2010-08-31 under 510(k) number K101605. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MYLABONE ULTRASOUND SYSTEM?

MYLABONE ULTRASOUND SYSTEM is a medical device that received FDA 510(k) clearance on 2010-08-31. The listed applicant is Esaote Europe B.V.. The 510(k) number is K101605.

When did MYLABONE ULTRASOUND SYSTEM receive FDA 510(k) clearance?

MYLABONE ULTRASOUND SYSTEM received FDA 510(k) clearance on 2010-08-31, under 510(k) number K101605.

Who is the listed applicant for MYLABONE ULTRASOUND SYSTEM?

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 MYLABONE ULTRASOUND SYSTEM?

The FDA product code for MYLABONE ULTRASOUND SYSTEM is IYN.

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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 SystemK083882MYLABFIVEK070903MYLAB40K062598IMT.LAB SOFTWAREK061755MYLAB15/20 NEW INDICATIONS ULTRASOUND SYSTEM

Related Devices (Code: IYN)

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.

K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLCK263182EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10 Diagnostic Ultrasound System; EVO XP30 Diagnostic Ultrasound System; EVO XP20 Diagnostic Ultrasound System; EVO XP10 Diagnostic Ultrasound System; EVO XC30 Diagnostic Ultrasound System; EVO XC20 Diagnostic Ultrasound System; EVO XC10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.K261313Vivid Explorer/Vivid Advanced/Vivid FocusGE Medical Systems Ultrasound and Primary Care DiagnosticsK254027Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90 CV/Marvo 90 Pro/Marvo 90 Exp/Marvo 90 Elite/Marvo Expert/Marvo 85/Marvo 85 Pro/Marvo 85 Exp/Marvo 85 Elite/Marvo Senior/Marvo 75 Elite/Marvo 75i/Fenix 95/Fenix 95 Elite/Fenix 90/Fenix 90 Elite/Fenix Expert/Fenix 85/Fenix 85 Elite/Fenix Senior/Fenix 75 Elite/Fenix 75i/Endo 80/Endo 90)Sonoscape Medical Corp.K261668Venue GoGE Medical Systems Ultrasound and Primary care Diagnostics, LLCK262311Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC

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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