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FDA 510(k)

MY01 Continuous Compartmental Pressure Monitor

K-Number: K242997 · 2025-03-13

ApplicantMY01, Inc.
Decision Date2025-03-13
Product CodeLXC
DecisionSubstantially Equivalent

Device Summary

MY01 Continuous Compartmental Pressure Monitor is the device name listed in this FDA 510(k) record. The listed applicant is MY01, Inc.. It received FDA 510(k) clearance on 2025-03-13 under 510(k) number K242997. The device is classified under product code LXC. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MY01 Continuous Compartmental Pressure Monitor?

MY01 Continuous Compartmental Pressure Monitor is a medical device that received FDA 510(k) clearance on 2025-03-13. The listed applicant is MY01, Inc.. The 510(k) number is K242997.

When did MY01 Continuous Compartmental Pressure Monitor receive FDA 510(k) clearance?

MY01 Continuous Compartmental Pressure Monitor received FDA 510(k) clearance on 2025-03-13, under 510(k) number K242997.

Who is the listed applicant for MY01 Continuous Compartmental Pressure Monitor?

The FDA 510(k) record lists MY01, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MY01 Continuous Compartmental Pressure Monitor?

The FDA product code for MY01 Continuous Compartmental Pressure Monitor is LXC.

Other records listing MY01, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: LXC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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