FDA 510(k)

6440 MyLabX90

K-Number: K230179 · 2023-11-29

Decision Date2023-11-29

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

6440 MyLabX90 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 2023-11-29 under 510(k) number K230179. 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 6440 MyLabX90?

6440 MyLabX90 is a medical device that received FDA 510(k) clearance on 2023-11-29. The listed applicant is Esaote, S.p.A.. The 510(k) number is K230179.

When did 6440 MyLabX90 receive FDA 510(k) clearance?

6440 MyLabX90 received FDA 510(k) clearance on 2023-11-29, under 510(k) number K230179.

Who is the listed applicant for 6440 MyLabX90?

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 6440 MyLabX90?

The FDA product code for 6440 MyLabX90 is IYN.

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

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 25 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.