Circul8 Pro— 510(k) K212731

Substantially Equivalent

Ortho8, Inc.

FDA 510(k) clearance K212731 for Circul8 Pro, Substantially Equivalent on 2021-11-15. Applicant: Ortho8, Inc..

Clearance details

Applicant: Ortho8, Inc.
Product code: Code JOW
Advisory panel: Cardiovascular
Date received: 2021-08-30
Decision date: 2021-11-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Rocklin, CA, US

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