GyroStim— 510(k) K220231

Substantially Equivalent

Ultrathera Technologies, Inc.

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

Clearance details

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

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