FDA 510(k)

MYLABSOGNO

K-Number: K121384 · 2012-05-23

Decision Date2012-05-23

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

MYLABSOGNO 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 2012-05-23 under 510(k) number K121384. 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 MYLABSOGNO?

MYLABSOGNO is a medical device that received FDA 510(k) clearance on 2012-05-23. The listed applicant is Esaote, S.p.A.. The 510(k) number is K121384.

When did MYLABSOGNO receive FDA 510(k) clearance?

MYLABSOGNO received FDA 510(k) clearance on 2012-05-23, under 510(k) number K121384.

Who is the listed applicant for MYLABSOGNO?

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 MYLABSOGNO?

The FDA product code for MYLABSOGNO 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)

View all 62 devices →

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.