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FDA 510(k)

PRESSUREALERT® Pressure Monitoring System

K-Number: K233096 · 2024-06-21

ApplicantPosition Health, LLC
Decision Date2024-06-21
Product CodeSBO
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PRESSUREALERT® Pressure Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Position Health, LLC. It received FDA 510(k) clearance on 2024-06-21 under 510(k) number K233096. The device is classified under product code SBO. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRESSUREALERT® Pressure Monitoring System?

PRESSUREALERT® Pressure Monitoring System is a medical device that received FDA 510(k) clearance on 2024-06-21. The listed applicant is Position Health, LLC. The 510(k) number is K233096.

When did PRESSUREALERT® Pressure Monitoring System receive FDA 510(k) clearance?

PRESSUREALERT® Pressure Monitoring System received FDA 510(k) clearance on 2024-06-21, under 510(k) number K233096.

Who is the listed applicant for PRESSUREALERT® Pressure Monitoring System?

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

What is the FDA product code for PRESSUREALERT® Pressure Monitoring System?

The FDA product code for PRESSUREALERT® Pressure Monitoring System is SBO.

Related Clinical Trials

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.

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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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