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FDA 510(k)

MY01 Continuous Compartmental Pressure Monitor

K-Number: K202635 · 2020-12-10

ApplicantMY01, Inc.
Decision Date2020-12-10
Product CodeLXC
DecisionSubstantially Equivalent

Device Summary

MY01 Continuous Compartmental Pressure Monitor is a medical device manufactured by MY01, Inc.. It received FDA 510(k) clearance on 2020-12-10 under approval number K202635. 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 2020-12-10. It is manufactured by MY01, Inc.. The 510(k) number is K202635.

When was MY01 Continuous Compartmental Pressure Monitor approved by the FDA?

MY01 Continuous Compartmental Pressure Monitor received FDA 510(k) clearance on 2020-12-10, under approval number K202635.

What company makes MY01 Continuous Compartmental Pressure Monitor?

MY01 Continuous Compartmental Pressure Monitor is manufactured by MY01, Inc..

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

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

Related Clinical Trials

NCT07614139 Continuous Glucose Monitoring Alerts, Accuracy, and Patient Outcomes in Adults With Inherited Metabolic Disorders COMPLETED NCT07499128 Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event ENROLLING_BY_INVITATION NCT05707806 Development and Validation of Learning and Decision-Making Tasks RECRUITING NCT07606495 Impact on Prognosis of Increased Sleep Quality Obtained by Personalized Night-time Nursing Care in Critically Ill Patients NOT_YET_RECRUITING NCT00702533 A New Method for Determining Gastric Acid Output Using a Wireless Capsule COMPLETED NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED

Related PubMed Literature

PMID: 40388896 Accuracy and Safety of a Continuous Noninvasive Blood Pressure Monitor in Neonates. Neonatology (2025)

Other Devices by MY01, Inc.

K193321MY01 Continuous Compartmental Pressure Monitor K210525MY01 Continuous Compartmental Pressure Monitor K220952MY01 Continuous Compartmental Pressure Monitor K242997MY01 Continuous Compartmental Pressure Monitor K251900MY01 Continuous Compartmental Pressure Monitor

Related Devices (Code: LXC)

K193321MY01 Continuous Compartmental Pressure MonitorMY01, Inc. K210525MY01 Continuous Compartmental Pressure MonitorMY01, Inc. K220952MY01 Continuous Compartmental Pressure MonitorMY01, Inc. K223509Compremium Compartment Compressibility Monitoring System (CPM#1)Compremium AG K242997MY01 Continuous Compartmental Pressure MonitorMY01, Inc. K251900MY01 Continuous Compartmental Pressure MonitorMY01, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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