GyroStim— 510(k) K220231

Name: FDA 510(k) clearance K220231
Creator: U.S. Food and Drug Administration
Published: 2022-04-27

Substantially Equivalent

Ultrathera Technologies, Inc.

FDA 510(k) clearance K220231 for GyroStim, Substantially Equivalent on 2022-04-27. Applicant: Ultrathera Technologies, Inc.. Device class: Unclassified.

Clearance details

Applicant: Ultrathera Technologies, Inc.
Product code: Code LXV
Device class: Unclassified
Advisory panel: Unknown
Date received: 2022-01-27
Decision date: 2022-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Colorado Springs, CO, 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.