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FDA 510(k)

HOTLINE 2 FLUID WARMER

K-Number: K001764 · 2000-08-09

ApplicantSims Level 1, Inc.
Decision Date2000-08-09
Product CodeLGZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HOTLINE 2 FLUID WARMER 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 2000-08-09 under 510(k) number K001764. The device is classified under product code LGZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOTLINE 2 FLUID WARMER?

HOTLINE 2 FLUID WARMER is a medical device that received FDA 510(k) clearance on 2000-08-09. The listed applicant is Sims Level 1, Inc.. The 510(k) number is K001764.

When did HOTLINE 2 FLUID WARMER receive FDA 510(k) clearance?

HOTLINE 2 FLUID WARMER received FDA 510(k) clearance on 2000-08-09, under 510(k) number K001764.

Who is the listed applicant for HOTLINE 2 FLUID WARMER?

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 HOTLINE 2 FLUID WARMER?

The FDA product code for HOTLINE 2 FLUID WARMER is LGZ.

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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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.

K011907SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM

Related Devices (Code: LGZ)

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.

K262532NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61)ICU MedicalK260988°M Warmer System with °M StationMequ A/SK252636Fluido Compact SystemThe Surgical Company International B.V.K251733Fluido® AirGuard SystemThe Surgical Company International BV (As Tsc Life)K232107°M Warmer SystemMequ A/SK211618Fluido Compact Blood and Fluid Warming SystemThe Surgical Company International B.V.

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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