FDA 510(k)

ClearUP Sinus Pain Relief

Numéro K : K182025 · 2019-01-02

Date de décision2019-01-02

Code produitGZJ

Comité consultatifNE

DécisionSubstantially Equivalent

Résumé du dispositif

ClearUP Sinus Pain Relief is the device name listed in this FDA 510(k) record. The listed applicant is Tivic Health Systems, Inc.. It received FDA 510(k) clearance on 2019-01-02 under 510(k) number K182025. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the ClearUP Sinus Pain Relief?

ClearUP Sinus Pain Relief is a medical device that received FDA 510(k) clearance on 2019-01-02. The listed applicant is Tivic Health Systems, Inc.. The 510(k) number is K182025.

When did ClearUP Sinus Pain Relief receive FDA 510(k) clearance?

ClearUP Sinus Pain Relief received FDA 510(k) clearance on 2019-01-02, under 510(k) number K182025.

Who is the listed applicant for ClearUP Sinus Pain Relief?

The FDA 510(k) record lists Tivic Health Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ClearUP Sinus Pain Relief?

The FDA product code for ClearUP Sinus Pain Relief is GZJ.

Essais cliniques associés

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Source officielle

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