FDA 510(k)

Bambino 3, S3 and S3 Swing, U3 and U3 Light, X

Numéro K : K220698 · 2023-02-16

Date de décision2023-02-16

Code produitIOR

Comité consultatifPM

DécisionSubstantially Equivalent

Résumé du dispositif

Bambino 3, S3 and S3 Swing, U3 and U3 Light, X is the device name listed in this FDA 510(k) record. The listed applicant is Panthera AB. It received FDA 510(k) clearance on 2023-02-16 under 510(k) number K220698. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Bambino 3, S3 and S3 Swing, U3 and U3 Light, X?

Bambino 3, S3 and S3 Swing, U3 and U3 Light, X is a medical device that received FDA 510(k) clearance on 2023-02-16. The listed applicant is Panthera AB. The 510(k) number is K220698.

When did Bambino 3, S3 and S3 Swing, U3 and U3 Light, X receive FDA 510(k) clearance?

Bambino 3, S3 and S3 Swing, U3 and U3 Light, X received FDA 510(k) clearance on 2023-02-16, under 510(k) number K220698.

Who is the listed applicant for Bambino 3, S3 and S3 Swing, U3 and U3 Light, X?

The FDA 510(k) record lists Panthera AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bambino 3, S3 and S3 Swing, U3 and U3 Light, X?

The FDA product code for Bambino 3, S3 and S3 Swing, U3 and U3 Light, X is IOR.

Essais cliniques associés

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Source officielle

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