FDA 510(k)

7600 Ultraschallsystem (MyLabC25); 7600 Ultraschallsystem (MyLabC30)

K-Nummer: K253310 · 2025-11-25

Entscheidungsdatum2025-11-25

ProduktcodeIYN

BeratungsausschussRA

EntscheidungSubstantially Equivalent

Produktübersicht

7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30) 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 2025-11-25 under 510(k) number K253310. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)?

7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30) is a medical device that received FDA 510(k) clearance on 2025-11-25. The listed applicant is Esaote, S.p.A.. The 510(k) number is K253310.

When did 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30) receive FDA 510(k) clearance?

7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30) received FDA 510(k) clearance on 2025-11-25, under 510(k) number K253310.

Who is the listed applicant for 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)?

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 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)?

The FDA product code for 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30) is IYN.

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Weitere Einträge mit Esaote, S.p.A. als Antragsteller

K261331I-Genius (100019400)K2532886450 Ultraschallsystem (MyLabE80); 6450 Ultraschallsystem (MyLabE85)K260746S-scan Open (100001800)K251901Magnifico Open (100009900)K2432536600 Ultraschallsystem (MyLabA50); 6600 Ultraschallsystem (MyLabA70)K2416716450 Ultraschallsystem (MyLabE80); 6450 Ultraschallsystem (MyLabE85)

Alle 25 Geräte anzeigen →

Verwandte Geräte (Code: IYN)

Offizielle Quelle

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