MY01 Continuous Compartmental Pressure Monitor— 510(k) K210525

Name: FDA 510(k) clearance K210525
Creator: U.S. Food and Drug Administration
Published: 2021-04-22

Substantially Equivalent

MY01, Inc.

FDA 510(k) clearance K210525 for MY01 Continuous Compartmental Pressure Monitor, Substantially Equivalent on 2021-04-22. Applicant: MY01, Inc.. Device class: Unclassified.

Clearance details

Applicant: MY01, Inc.
Product code: Code LXC
Device class: Unclassified
Advisory panel: Unknown
Date received: 2021-02-23
Decision date: 2021-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montreal, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code LXC

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K193321 — MY01 Continuous Compartmental Pressure Monitor2020-07-30

Recalls naming K210525

K-number listed on FDA's recall record

Z-2384-2021 — MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001Class II·Terminated·MY01, INC.·20210628

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K210525.

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