MY01 Continuous Compartmental Pressure Monitor— 510(k) K242997

Name: FDA 510(k) clearance K242997
Creator: U.S. Food and Drug Administration
Published: 2025-03-13

Substantially Equivalent

MY01, Inc.

FDA 510(k) clearance K242997 for MY01 Continuous Compartmental Pressure Monitor, Substantially Equivalent on 2025-03-13. Applicant: MY01, Inc.. Device class: Unclassified.

Clearance details

Applicant: MY01, Inc.
Product code: Code LXC
Device class: Unclassified
Advisory panel: Unknown
Date received: 2024-09-26
Decision date: 2025-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montreal, CA

Download summary PDF View on FDA.gov ↗

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