Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

3M Bair Hugger Temperature Management System (Model 675)

K-Number: K210603 · 2021-03-30

Applicant3M Company
Decision Date2021-03-30
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

3M Bair Hugger Temperature Management System (Model 675) is a medical device manufactured by 3M Company. It received FDA 510(k) clearance on 2021-03-30 under approval number K210603. 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 3M Bair Hugger Temperature Management System (Model 675)?

3M Bair Hugger Temperature Management System (Model 675) is a medical device that received FDA 510(k) clearance on 2021-03-30. It is manufactured by 3M Company. The 510(k) number is K210603.

When was 3M Bair Hugger Temperature Management System (Model 675) approved by the FDA?

3M Bair Hugger Temperature Management System (Model 675) received FDA 510(k) clearance on 2021-03-30, under approval number K210603.

What company makes 3M Bair Hugger Temperature Management System (Model 675)?

3M Bair Hugger Temperature Management System (Model 675) is manufactured by 3M Company.

What is the FDA product code for 3M Bair Hugger Temperature Management System (Model 675)?

The FDA product code for 3M Bair Hugger Temperature Management System (Model 675) 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 NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT05174312 Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve Decongestion Management System (DMS) COMPLETED

Related PubMed Literature

PMID: 38493931 Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard. Methods (San Diego, Calif.) (2024) PMID: 36632328 Integrating real-world data to assess cardiac ablation device outcomes in a multicenter study using the OMOP common data model for regulatory decisions: implementation and evaluation. JAMIA open (2023) 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) PMID: 29082710 [How to adapt to the requirements of "clinical value-oriented drug innovation" for pharmaceutical research in application process of new traditional Chinese medicine]. Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica (2017)

Other Devices by 3M Company

K163207Filtek One Bulk Fill Restorative K1605463M Attest Rapid Readout Biological Indicator K1713733M Bair Hugger Model 675 Total Temperature Management System K1703213M Comply Hydrogen Peroxide Chemical Indicator 1248 K1705633M Comply Hydrogen Peroxide Indicator Tape K1710033M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader

View all 51 devices →

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.

↑