FDA 510(k)

MYLAB 90 ULTRASOUND IMAGING SYSTEM, MODEL 6100

K-Number: K051837 · 2005-07-20

Decision Date2005-07-20

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

MYLAB 90 ULTRASOUND IMAGING SYSTEM, MODEL 6100 is the device name listed in this FDA 510(k) record. The listed applicant is Esaote, S.p.A.. It received FDA 510(k) clearance on 2005-07-20 under 510(k) number K051837. 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 MYLAB 90 ULTRASOUND IMAGING SYSTEM, MODEL 6100?

MYLAB 90 ULTRASOUND IMAGING SYSTEM, MODEL 6100 is a medical device that received FDA 510(k) clearance on 2005-07-20. The listed applicant is Esaote, S.p.A.. The 510(k) number is K051837.

When did MYLAB 90 ULTRASOUND IMAGING SYSTEM, MODEL 6100 receive FDA 510(k) clearance?

MYLAB 90 ULTRASOUND IMAGING SYSTEM, MODEL 6100 received FDA 510(k) clearance on 2005-07-20, under 510(k) number K051837.

Who is the listed applicant for MYLAB 90 ULTRASOUND IMAGING SYSTEM, MODEL 6100?

The FDA 510(k) record lists Esaote, S.p.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MYLAB 90 ULTRASOUND IMAGING SYSTEM, MODEL 6100?

The FDA product code for MYLAB 90 ULTRASOUND IMAGING SYSTEM, MODEL 6100 is IYN.

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Related Devices (Code: IYN)

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.