Ultrast Gel— 510(k) K211691

Substantially Equivalent

Ultrast, Inc.

FDA 510(k) clearance K211691 for Ultrast Gel, Substantially Equivalent on 2021-12-22. Applicant: Ultrast, Inc.. Device class: 2.

Clearance details

Applicant: Ultrast, Inc.
Product code: Code MUI
Device class: Class 2
Regulation: 21 CFR 892.1570
Advisory panel: Radiology
Date received: 2021-06-02
Decision date: 2021-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oceanside, NY, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.