FDA 510(k)

MODEL 6150 (MYLAB70) AND MODEL 6100 (MYLAB90)

K-Number: K081386 · 2008-09-25

Decision Date2008-09-25

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

MODEL 6150 (MYLAB70) AND MODEL 6100 (MYLAB90) 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 2008-09-25 under 510(k) number K081386. 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 MODEL 6150 (MYLAB70) AND MODEL 6100 (MYLAB90)?

MODEL 6150 (MYLAB70) AND MODEL 6100 (MYLAB90) is a medical device that received FDA 510(k) clearance on 2008-09-25. The listed applicant is Esaote, S.p.A.. The 510(k) number is K081386.

When did MODEL 6150 (MYLAB70) AND MODEL 6100 (MYLAB90) receive FDA 510(k) clearance?

MODEL 6150 (MYLAB70) AND MODEL 6100 (MYLAB90) received FDA 510(k) clearance on 2008-09-25, under 510(k) number K081386.

Who is the listed applicant for MODEL 6150 (MYLAB70) AND MODEL 6100 (MYLAB90)?

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 MODEL 6150 (MYLAB70) AND MODEL 6100 (MYLAB90)?

The FDA product code for MODEL 6150 (MYLAB70) AND MODEL 6100 (MYLAB90) is IYN.

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Other records listing Esaote, S.p.A. as applicant

K261331I-Genius (100019400)K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)K260746S-scan Open (100001800)K251901Magnifico Open (100009900)K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)

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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.