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FDA 510(k)

IOB Temperature Management System

K-Number: K231596 · 2023-06-30

ApplicantIob Medical, Inc.
Decision Date2023-06-30
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IOB Temperature Management System is a medical device manufactured by Iob Medical, Inc.. It received FDA 510(k) clearance on 2023-06-30 under approval number K231596. The device is classified under product code DWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IOB Temperature Management System?

IOB Temperature Management System is a medical device that received FDA 510(k) clearance on 2023-06-30. It is manufactured by Iob Medical, Inc.. The 510(k) number is K231596.

When was IOB Temperature Management System approved by the FDA?

IOB Temperature Management System received FDA 510(k) clearance on 2023-06-30, under approval number K231596.

What company makes IOB Temperature Management System?

IOB Temperature Management System is manufactured by Iob Medical, Inc..

What is the FDA product code for IOB Temperature Management System?

The FDA product code for IOB Temperature Management System is DWJ.

Related Clinical Trials

NCT06011187 Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery COMPLETED NCT07499128 Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event ENROLLING_BY_INVITATION NCT05701917 DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis RECRUITING NCT07606495 Impact on Prognosis of Increased Sleep Quality Obtained by Personalized Night-time Nursing Care in Critically Ill Patients NOT_YET_RECRUITING NCT05174312 Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve Decongestion Management System (DMS) COMPLETED NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED

Related PubMed Literature

PMID: 32459382 Safety Assessment of an A-Scan Ultrasonic System for Ophthalmic Use. Journal of ultrasound in medicine : official journal of the American Institute of Ultrasound in Medicine (2020)

Other Devices by Iob Medical, Inc.

K162679IOB Temperature Management System K190221IOB Warming Blankets K201896ivi N3003 Surgical face Mask, ivi N6006 Surgical mask K221669IOB Warming Blankets K232638FilteredFlo Warming Blankets

Related Devices (Code: DWJ)

K152266Altrix Precision Temperature Management SystemStryker Medical K161602Arctic Sun Temperature Management SystemMedivance, Inc. K1713733M Bair Hugger Model 675 Total Temperature Management System3M Company K171149Altrix Temperature Management WrapsStryker Medical K171234Mistral-Air Warming UnitThe Surgical Company International BV (As the 37company) K162679IOB Temperature Management SystemIob Medical, 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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