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FDA 510(k)

SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM

K-Number: K011907 · 2001-12-18

ApplicantSims Level 1, Inc.
Decision Date2001-12-18
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sims Level 1, Inc.. It received FDA 510(k) clearance on 2001-12-18 under 510(k) number K011907. 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 SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM?

SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM is a medical device that received FDA 510(k) clearance on 2001-12-18. The listed applicant is Sims Level 1, Inc.. The 510(k) number is K011907.

When did SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM receive FDA 510(k) clearance?

SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM received FDA 510(k) clearance on 2001-12-18, under 510(k) number K011907.

Who is the listed applicant for SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM?

The FDA 510(k) record lists Sims Level 1, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM?

The FDA product code for SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM is DWJ.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Sims Level 1, 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.

K001764HOTLINE 2 FLUID WARMER

Related Devices (Code: DWJ)

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.

K262089Disposable Warming BlanketHangzhou Tappa Medical Technology Co., Ltd.K261437Mistral-Air® Warming SystemThe Surgical Company International B.V., doing business as TSC LifeK260278ThermAffyx(TM) Patient Safety SystemStihler Electronic GmbHK260903Hot Pink Pad Warming SystemXodus Medical, Inc.K252861Warming SystemHangzhou Tappa Medical Technology Co., Ltd.K251974Arctic Sun Temperature Management System (Model 5000)Medivance, Inc.

Official Source

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

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