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FDA 510(k)

WARMER 2000LD

K-Number: K021289 · 2002-06-26

ApplicantO.R. Solutions, Inc.
Decision Date2002-06-26
Product CodeLHC
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

WARMER 2000LD is the device name listed in this FDA 510(k) record. The listed applicant is O.R. Solutions, Inc.. It received FDA 510(k) clearance on 2002-06-26 under 510(k) number K021289. The device is classified under product code LHC. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WARMER 2000LD?

WARMER 2000LD is a medical device that received FDA 510(k) clearance on 2002-06-26. The listed applicant is O.R. Solutions, Inc.. The 510(k) number is K021289.

When did WARMER 2000LD receive FDA 510(k) clearance?

WARMER 2000LD received FDA 510(k) clearance on 2002-06-26, under 510(k) number K021289.

Who is the listed applicant for WARMER 2000LD?

The FDA 510(k) record lists O.R. Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WARMER 2000LD?

The FDA product code for WARMER 2000LD is LHC.

Related Clinical Trials

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Other records listing O.R. Solutions, 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.

K051979ORS MODEL 6000 ENDOSCOPE HOLDERK0232831075LD HUSH-SLUSHK023282ORS-3000LDK021288ORS-1000LDK960836DMS-9000K953654ORS-111

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Related Devices (Code: LHC)

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.

K153713Getinge Series Warming CabinetGetinge Sourcing, LLCK152522ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming DrapesEcolab, Inc.K083417INTRATEMP SOLUTION WARMERC Change Surgical, LLCK080609SWC/DWC WARMING CABINETSMac MedicalK051819C CHANGE SOLUTION WARMERC Change Surgical, LLCK0232831075LD HUSH-SLUSHO.R. Solutions, 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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